Broad spectrum pharmacological composition for treatment of various infections and diseases and methods of use

ABSTRACT

A pharmacological composition for the treatment of bacterial and protozoal infections in a patient. The preferred pharmacological composition comprises a pharmaceutical carrier and an active composition selected from the group consisting of: a) an amount of sodium oxalate and an amount of oxalic acid, b) an amount of sodium citrate and an amount of citric acid, or c) mixtures of a) and b). The amounts and weight ratios of a) the sodium oxalate and oxalic acid, and b) the sodium citrate and citric acid in the active composition are such as to produce a safe and effective pharmacological composition. Sodium salts of other carboxylic acids may be used. The invention also relates to the method of using the pharmacological composition for the safe and effective treatment of bacterial infections, protozoal infections and dermatological diseases.

RELATED APPLICATIONS

This application (CIP-3) is a continuation in part application of U.S.application Ser. No. 15/891,839 filed on Feb. 8, 2018 now U.S. patentSer. No. 10/493,050 issued on Dec. 3, 2019 (CIP-2), which is acontinuation in part of U.S. application Ser. No. 15/062,156 filed onMar. 6, 2016, now U.S. Pat. No. 9,962,347, issued on May 8, 2018(CIP-1), which is a continuation in part of U.S. application Ser. No.13/913,555 filed on Jun. 10, 2013, now U.S. Pat. No. 9,301,935 issued onApr. 5, 2016 (Parent), the entire disclosures of all of these patentsand applications are incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a pharmacological composition that is asafe and effective broad spectrum antibiotic, particularly against grampositive and gram negative bacteria, anti-protozoal, and can be used forthe treatment of various diseases and for the treatment of variousdermatological disorders in patients. In particular, the composition ofthis invention, inhibits the growth or destroys the bacteria, andinhibits or destroys protozoal infections. In particular the compositionof this invention ameliorates, prevents and/or treats bacterialinfectious diseases. The active ingredients in the preferredpharmacological composition are a) a mixture of sodium citrate andcitric acid, and/or b) a mixture of sodium oxalate and oxalic acid.However, similar mixtures of the active cation of sodium salts withanions of organic acids may be derived from other organic acids otherthan citric and oxalic acids, for example, lactic acid, salicylic acid,tartaric acid, glycolic acid, ascorbic acid, maleic acid, succinic acid,mandelic acid, dodecylbenzenesulfonic acid, propionic acid, gluconicacid, malic acid, benzoic acid, aspartic acid, acetic acid, glutamicacid, adipic acid, hexanoic acid, octanoic acid, nonanoic acid, decanoicacid, undecanoic acid and combinations thereof. The compositions of thisinvention may be administered orally.

Related Art

Applicant is aware of the following references that may be relevant tothis invention:

US Published Application 2007/0027119 to Ahmed et al. describes anonirritating antimicrobial liquid composition with citric acid andoxalic acid combination and alcohol used in skin treatment, primarily ateat treatment for cows.

US Published Application 2007/0184016 to Macinga et al. describes apre-surgical disinfectant with alcohol and citric acid, oxalic acid ormixtures thereof.

US Published Application 2010/0234460 to Foret et al. describesdisinfectant solution for the treatment of hoof diseases that contains asurfactant and one or more carboxylic acids, e.g., citric acid andoxalic acid.

US Published Application 2010/0292333 to Mladenovich describes fungalinfection treatment composed of two or more low-molecular weight organicacids, e.g., oxalic acid and citric acid, and their salts.

US Published Application 2011/0152384 to Gunn et al. describes skin carecomposition with emulsifier and organic acids, including oxalic acid orcitric acid.

US Published Application 2012/0015809 to He et al. describes a surfacecleaner with formic acid and an enhancing component of citric acid thatmay be mixed with oxalic acid for the control of pests, including fungi,oomycetes, nematodes and weeds.

US Published Application 2012/0269751 to Stal describes a topicalcomposition of physiologically acceptable carboxylic acid such as citricacid and/or oxalic acid for the treatment of skin and nail conditions,i.e., microbiological infections of the nail (onychomycosis), warts.

US Published Application 2012/0302642 to Post abrasive acidic cleaningcomposition for hard surfaces, e.g., lavatory surfaces, which includes acolloid forming clay, a thickener, a surfactant and antimicrobialamounts of an organic acid and an abrasive constituent. The organic acidmay be a citric acid, oxalic acid or mixtures thereof.

U.S. Pat. No. 5,639,459 to Bouras describes a composition to treat hairloss, baldness and alopecia that embodies using oxalates, e.g., ammoniumoxalate meta. The use of citric acid is in conjunction therewith istaught. The treatment “ . . . enhances the aesthetic appearance of scalpand skin.”

U.S. Pat. No. 5,648,389 to Gans et al. describes a topical treatment fordermatological disorders using zinc compound and ahydroxy acid that maybe citric acid and the zinc compound may be zinc oxalate.

U.S. Pat. No. 6,114,389 to Bouras describes a method for treatingdiseases of the skin by applying a pharmaceutically acceptable oxalate,e.g., a metal oxalate in an ointment.

U.S. Pat. No. 6,407,141 to Hart describes hemo-therapeuticchemo-preventative composition for treating vascular diseases thatcontains oxalic acid and/or oxalate.

U.S. Pat. No. 6,936,579 to Urban describes a hard surface cleaningcomposition with citric acid and oxalic acid.

U.S. Pat. No. 6,982,097 to Mingzhong et al. describes a biocidecomposition for disinfecting water that includes a filler of sodiumcitrate, oxalic acid, sodium bromide, and a halogen releasing compound.

U.S. Pat. No. 7,517,842 to Barnhart et al. describes an antimicrobialhand wash formulation with a cationic surfactant produced from theneutralization of an amid amine with an acid and an active ingredient.The acid may be an oxalic acid or citric acid as the acid neutralizer.

U.S. Pat. No. 7,618,658 to Tsuchida et al. describes an antimicrobialcomposition of Sasaextract and the use of citric acid or oxalic acid toimprove the antimicrobial activity.

U.S. Pat. No. 7,883,715 to Abraham et al. describes enhancing theherbicidal effectiveness of glyphosate through the addition of adicarboxylic acid, in particular oxalic acid.

Citric Acid

Citric acid is well known. Citric acid was first isolated in 1784 by thechemist Wilhelm Scheele, who crystallized it from lemon juice.Industrial-scale citric acid production first began in 1890. In 1893, C.Wehmer discovered penicillium mold could produce citric acid. In 1917,American food chemist James Currie discovered certain strains of themold Aspergillus niger could be efficient citric acid producer.

Citric Acid, 2-hydroxytricarboxylic acid is of biological origin and itsfunctionality makes it suitable for wide range of application. Thepresence of one hydroxyl group and 3 carboxyl groups permits theformation of complex molecules, which may be soluble and capable ofmodifying the solubility of constituent's material. Citric acids, Oxalicacid, along with lactic acid, acidulant and its salts are preferredbuffers in pharmaceutical preparation. Citric acid crystallizes from acold aqueous solution as monohydrate (C6H8O7H2O). The crystal is colorless. It is optically inactive. Citric acid is strong organic acid asindicated by the first dissociation constant which is 8.2×10⁻⁴ at 18degree Celsius. The second and third dissociation constants are1.77×10⁻⁴ and 3.9×10⁻⁷ respectively. Citric acid is readily soluble inwater and in various organic compounds.

Citric acid is a natural preservative present in citrus fruits. It iswhite hygroscopic crystalline powder. It can exist either in ananhydrous (water-free) form or as monohydrate. Citric acid alsodissolves in absolute (anhydrous) ethanol. It is also used to add anacidic or sour taste to foods and drinks and is used mainly asacidifier, flavoring and chelating agent.

The FDA lists citric acid in the Nov. 20, 1959 issue of the federalregister (23-a) as a substance that is generally recognized as safe forspecific use in compliance with the Food additive amendment of 1958.Even at high concentrations citric acid is not injurious in contact withskin.

After oral administration of citric acid the citrate ion is rapidly andalmost completely oxidized, less than 1% being excreted unchanged inurine. Intravenous injection shortens, coagulation times of the bloodbut in vitro, the citrate ion acts as an anticoagulant.

With sodium bicarbonate, citric acid is used in many effervescent powderand tablets to liberate carbon dioxide when added to water. Citric acidsalt's such as sodium citrate and potassium citrate and citric acid arealso used in different remedies like in CITRO-SODA® (AbbottLaboratories) which is characterized as a gastric antacid and urinaryalkalinizing agent.

Sodium Citrate

Sodium Citrates are used as acidity regulators in food and drinks, andalso as emulsifiers for oils, e.g., with citric acid it is used as abuffering agent for controlling PH in the preparation of candies Inpharmaceutical preparations, such as effervescent tablets, powders anddroughts, sodium citrate is used as blood and urinary alkalizer and inlarge dosages as a saline cathartic. Due to its anticoagulant propertyof citrate ion, sodium citrate is extensively employed for this purpose.And the final product is known officially in US Pharmacopeia ascitrated, normal human plasma when blood is drawn from an individualunder aseptic condition into sterile bottle. Such bottle contains 50 mlof a 4% solution of sodium citrate in isotonic sodium chloride solution.To this is added 50 ml of whole blood. Sodium Citrate prevents bloodfrom coagulation.

OBJECTS AND SUMMARY OF THE INVENTION

The present invention is directed to a pharmacological composition forthe treatment of bacterial and protozoal infections in a patient. Thepharmacological composition comprises a pharmaceutical carrier and anactive composition selected from the group consisting of an amount of anactive cation sodium salt with an anion organic acid and an amount ofthe organic. The organic acid is selected from the group consisting ofcitric acid, oxalic acids, lactic acid, salicylic acid, tartaric acid,glycolic acid, ascorbic acid, maleic acid, succinic acid, mandelic acid,dodecylbenzenesulfonic acid, propionic acid, gluconic acid, malic acid,benzoic acid, aspartic acid, acetic acid, glutamic acid, adipic acid,hexanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoicacid or combinations thereof. The amounts and weight ratios of suchamounts in the active composition result in a safe and effectivepharmacological composition.

The preferred pharmacological composition comprises a pharmaceuticalcarrier and an active composition selected from the group consisting of:

a. an amount of sodium oxalate and an amount of oxalic acid,

b. an amount of sodium citrate and an amount of citric acid, or

c. mixtures of a. and b,

The amounts and weight ratios of a) the sodium oxalate and oxalic acid,and b) the sodium citrate and citric acid in the active composition aresuch as to produce a safe and effective pharmacological composition.

The invention also relates to the method of using the pharmacologicalcomposition for the safe and effective treatment of bacterialinfections, protozoal infections and dermatological diseases.

DETAILED DESCRIPTION OF THE INVENTION

Unless specified otherwise, all ingredients are in weight/weight percent(w/w %), i.e., the weight of the ingredient relative to the weight ofthe final composition described as a percentage.

A “therapeutically effective amount” means the amount of thepharmacological composition described herein that will disinfect,inactivate or significantly diminish the population of a microorganismor protozoa, or effectively treat a given disease or condition, e.g.,bacterial infection, protozoal infection, or dermatological diseases orinfections.

Preferred Active Composition: Sodium Oxalate and Oxalic Acid

The theoretical stoichiometric ratio of oxalic acid and sodiumbicarbonate for the preparation of sodium oxalate is 1:1.33 weightratios. Theoretically this produces 100% sodium oxalate.

The active composition used in the pharmacological compositions of thisinvention uses a 1:1 weight ratio of oxalic acid to sodium bicarbonateto make the active composition. This produces a final active compositionwith an excess of oxalic acid mixed with sodium oxalate. This imparts asafe and efficacious medicinal activity to the composition. The activecomposition maintains a pH of about 6 which acceptable for patient use.

The highly preferred composition is a mixture of 78.44% sodium oxalateand 21.56% oxalic acid. A preferred range is about 73% to about 83%Sodium oxalate and about 17% to about 27% oxalic acid. It is to beunderstood however that various weights and ratios of sodium oxalate andoxalic acid may be used as long as a safe and efficaciouspharmacological composition is produced.

Sodium Oxalate—Oxalic Acid Mixture

a) Stoichiometric Formulation Ratio:

b) Method of Producing Active Composition:

Method of Preparation of Mixture of Sodium Oxalate—Oxalic Acid as ActiveIngredient

Mix one part oxalic acid and one part sodium bicarbonate than graduallyspray sterile water into the mixture to make reaction. The water ismerely the medium for the reaction. Carbon dioxide is evaporated rapidlyand water is gradually evaporated. The remaining product is a mixture of78.44% Sodium Oxalate and 21.56% Oxalic acid active ingredient. Theproduct is in the form of crystals. The product is then dried andcrushed to fine particles to produce an active composition suitable forformulation into the pharmacological formulations of this invention.

Preferred Active Composition: Sodium Citrate and Citric Acid

The theoretical stoichiometric ratio of citric acid and sodiumbicarbonate for the preparation of sodium oxalate is 1:1.2 weightratios. Theoretically this produces 100% sodium citrate. The activecomposition used in the pharmacological compositions of this inventionuses a 1:1 weight ratio of citric acid to sodium bicarbonate to make theactive composition. This produces a final active composition with anexcess of citric acid mixed with sodium citrate. This imparts a safe andefficacious medicinal activity to the composition. The activecomposition maintains a pH of about 6 which acceptable for patient use.

The highly preferred composition is a mixture of 87% sodium citrate and13% citric acid. A preferred range is about 82% to about 92% Sodiumcitrate and about 8% to about 18% citric acid. It is to be understoodhowever that various weights and ratios of sodium citrate and citricacid may be used as long as a safe and efficacious pharmacologicalcomposition is produced.

Sodium Citrate—Citric Acid Mixture

a) Stoichiometric Formulation Ratio:

b) Method of Producing Active Composition:

Method of Preparation of Mixture of Sodium Citrate—Citric Acid as ActiveIngredient

Mix one part citric acid and one part sodium bicarbonate than graduallyspray sterile water into the mixture to make reaction. The water ismerely the medium for the reaction. Carbon dioxide is evaporated rapidlyand water is gradually evaporated. The remaining product is a mixture of87% Sodium citrate and 13% citric acid active ingredient. The product isin the form of crystals. The product is then dried and crushed to fineparticles to produce an active composition suitable for formulation intothe pharmacological formulations of this invention.

Similar mixtures of sodium salts and organic acids may be derived fromother organic acids other than citric and oxalic acids, for example,lactic acid, salicylic acid, tartaric acid, glycolic acid, ascorbicacid, maleic acid, succinic acid, mandelic acid, dodecylbenzenesulfonicacid, propionic acid, gluconic acid, malic acid, benzoic acid, asparticacid, acetic acid, glutamic acid, adipic acid, hexanoic acid, octanoicacid, nonanoic acid, decanoic acid, undecanoic acid and combinationsthereof.

The pharmacological compositions of this invention include apharmaceutically acceptable carrier that does not adversely affect theefficacy and safety of the compositions. The carrier is highly dependenton the selected modality of treatment. For example, the pharmacologicalcompositions may be orally administered, topically applied, administeredas a suppository, and as an injectable. The carrier may include, forexample, an additive selected from a buffering agent, an emollient, ahumectant, a preservative, a surfactant or wetting agent, a viscositycontrol agent, a colorant, an opacifying agent, and any combinationsthereof.

The pharmacological composition may also include additional suitablecomponents, for instance fragrances, emulsifiers, detergents,antioxidants and preservatives, and other ingredients commonly used inpharmaceutical and cosmetic formulations. Preferably, the composition isessentially free of water, which increases the stability of thecomposition over time. Preferably, the composition is formulated as afluid composition such as a cream, or more preferably as a liquidcomposition, which is relatively easy to apply to the human skin and/ornails.

Methods of preparing the pharmacological compositions may involvedissolving a desired concentration of the active composition and,alternatively, any desired additives in a selected pharmaceuticalcarrier. The solution is then mixed, for example in a mixer, to form afinal pharmacological composition. Useful concentrations are those wherethe percentage of the active composition by total weight of thecomposition is preferably from about 0.02 to 20% by weight of thepharmacological composition. The pharmaceutical carrier may be presentfrom 80 to 99.98% by weight. More preferably, this is from about 0.03 to15% of each active composition and from about 85% to 99.97% of apharmaceutical carrier.

The phrase “therapeutically effective amount” is intended to qualify theamount of the pharmacological composition which will achieve the goal ofthe composition, e.g., reduction of bacteria, reduction of protozoalactivity, and treatment of dermatological diseases. “Therapeuticallyeffective” may also refer to improvement in disorder severity or thefrequency of incidence over no treatment.

The term “topical” and “locally” application shall refer to anycomposition applied on skin, eye, auditory canal, oral mucosa and invaginal mucosa where the application of my invention is indicated.

Broadly, the pharmacological composition of this invention is used forthe treatment of bacterial and protozoal infections in a patient andtreating a dermatological disease in a patient.

The pharmacological compositions of this invention may also containwater and a “structuring agent” such as carbomers or other thickeningpolymers, for example, xanthan gum, carrageenan gum or the like. Thecompositions may be made into a wide variety of product types thatinclude but are not limited to lotions, sprays, wipes, and make-up suchas foundations. These product types may comprise several types ofcosmetically-acceptable topical carriers. Preferably the carrier isalcohol free.

Preferred carriers for the active composition, based on the foregoingcriteria for use, are:

Preferred Carrier Compositions (by Weight):

-   -   1) 20% emulsifying wax, 10% Liquid paraffin and 70% water.    -   2) 20% emulsifying wax and 80% water.    -   3) 2% carboxymethyl cellulose and 98% water.        Antibiotic

More specifically the pharmacological compositions are used as a broadspectrum antibiotic. Preferably, the mixture of sodium oxalate andoxalic acid is used alone as the active composition, as is the mixtureof sodium citrate and citric acid. A mixture of these activecompositions may also be used.

The pharmacological composition of this invention may be used orally,topically in the form of ointment, cream, and drops (for eye and ear)through suppository and parentally by injection, infusion orimplantation. The pharmacological compositions of this invention areeffective against gram positive and gram negative bacteria, for example:Staphylococcus aureus, Epidermidis, Streptococcus Aagalactae, E. coli,Klebsilla, Proteus, Entrobacter, Entrococcous, Citrobacter,Propionibacterium acne, Corynebacterium, B. Subtilis, and Serratia butnot limited to these.

The pharmacological composition of this invention may be used whereantibiotics are indicated in the treatment of infections caused bypathogens sensitive to it, for example in pneumonia, chronic bronchitis,acute exacerbation of chronic bronchitis, community acquired pneumonia,sinusitis otitis media, urinary tract infection, genital tract gonococciurethritis, non gonococci urethritis, cervicitis, skin and soft tissueinfections, chalazion, conjunctivitis, otitis externa, otitis mediatympanits, perotinitis, cholecystis, appendicitis, folliculitis,paronychia, carbuncle and other such infections.

Protozoa

The pharmacological compositions of this invention may be used forreducing protozoa in a patient having a protozoal infection, i.e., ananti-protozoal composition. The composition acts against trichomonadswhich causes trichomoniasis. It also acts against Antamoeba histolytica,causes amaebiasis and Giardia, causes Giardiasis the gastroenteritisintestinalis. Some other protozoa are human parasites, causing diseases.Examples of diseases caused by protozoa, which the compositions of thisinvention are effective against, are Malaria, Amoebiasis, Giardiasis,Toxoplasmosis, Cryptosporidiosis, Trichomoniasis, Chagas disease,Leishmaniasis, Sleeping Sickness, and Dysentery.

Dermatological Diseases

The pharmacological compositions of this invention may be used fortreating dermatological diseases in a patient having such a disease.Preferably, the mixture of sodium oxalate and oxalic acid is used aloneas the active composition, as may the mixture of sodium citrate andcitric acid. A preferred dermatological pharmacological composition ofthis invention for the treatment of skin diseases includes about 1% toabout 10% of the sodium oxalate and oxalic acid mixture as the activecomposition or about 1% to about 10% of the sodium citrate and citricacid as the active composition. Optionally, about 1% to about 4%Salicylic acid, steroid (colobetasol, hydrocortisone), Benzoic acid andzinc oxide may be added to enhance the effect of composition. For dryskin, an oily base may be used. For an oily skin, a water base may beused. If the pharmacological composition needs to be taken orally, anontoxic (edible) water based carrier should be used. If thepharmacological composition is for vaginal use a water or oil basecarrier should be used.

Hyperhidrosis

The pharmacological compositions of this invention may also be used fortreating hyperhidrosis. Hyperhidrosis is a disease of excessiveproduction of sweat, particularly from the palms, soles and axillae.Hyperhidrosis may be due to pharmacologically acting agents acting onthe sweat glands, abnormal stimulation of the sympathetic path-waysbetween the hypothalamus and nerve endings or over activity of one ofthree different centers responsible for thermoregulatory, mental andgustatory centers or of unknown cases.

Whatever the underlying cause of hyperhidrosis, the pharmacologicalcompositions of this invention act locally to suppress and/or curehyperhidrosis by developing anhidrotic areas by directly acting on thesweat glands (eccrine and apocrine glands).

The preferred treatment is with a topical pharmacological compositionhaving 2% to 10% (by weight) of a mixture of sodium citrate and citricacid or, alternatively with a 2% to 10% mixture of sodium oxalate andoxalic acid.

Lice

The pharmacological compositions of this invention may also be used fortreating lice. This is accomplished by the direct interference by thecompositions of this invention with the respiratory function of the liceby blocking the spiracles of the lice. This is accomplished without anyadverse effect on the skin, and particularly to children that would usethe composition.

Lice are members of phthiraptera. They spend their entire life on thehost, e.g., animals or people. Man is parasitized by two species. Twospecies are from the sub-order anoplura, and are the Pediculushumanusand pithrus pubis species. There are two species of Pediculus humanus;they are P. humanus capitis (head lice) and P. humanus humanus (body orclothing lice). Pithirus pubis (pubic or crab lice) is morphologicallyquite distinct from Pediculus humanus. Infection with pubic lice istermed pithiriasis while infection with Pediculus humanus is termedPediculosis.

The pharmacological compositions of this invention produce a multiaction affect to eradicate the lice. It is pediculicider and ovicider.Eggs of head lice, and empty egg cases are cemented to hair shaft with achitinous cement material secreted by the female accessory glands andare difficult to dislodge. The compositions of this invention dissolvechitinous material to loosen the eggs so that they can be removed bycombing the hair. The pharmacological compositions also haveantihydrotic effect and create anhidrotic area in scalp which creates anunfavorable environment for lice development. The compositions whenapplied locally will kill the lice within 24 hours.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Scabies

The pharmacological compositions of this invention may also be used fortreating Scabies. This is a disease found in man and animal. It iscaused by Sarcoptes scabie and Notoedres cati. Scabies are caused bymites of Arachnida class Sarcoptes scabiei.

The mite shows a preference for certain sites in which to burrow andappear to avoid areas with a high density of pilosebeceous follicle. Thenumber of adult female mites in individual suffering from the commonform of scabies is about twelve. Only in crusted scabies there are alarge number of mites present.

Scabies is usually transmitted by close physical contact such asprolonged hand holding, bed sharing. Poor hygienic condition, encouragethe spread of scabies. Scabies is usually found in developing countriesand regions of poverty.

The pharmacological compositions of this invention when locally appliedare scabicider and functions to minimize secretions from the sebaceousglands. Secretions from the sebaceous glands provide a suitableenvironment for the growth of mites in humans as well as in animals. Thecompositions provide a “double action” for the treatment of thisdisease.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Oral treatment for scabies may also be given for short period oftime orally which also work as scabicider.

Fish Malodor

The pharmacological compositions of this invention may also be used fortreating Fish malodor caused by sweating, vaginal discharge and/or frommouth and nares. Trimethylaminuria (TMAU), also known as fish odorsyndrome or fish malodor syndrome, is a rare metabolic disorder thatcauses a defect in the normal production of the enzyme flavin containingmonooxygenase (“FM03”). When FMO3 is not working correctly or if notenough enzyme is produced, the body loses the ability to properlyconvert trimethylamine (TMA) from precursor compounds in food digestioninto trimethylamine oxide (TMAO) through a process called N-oxygenation.Trimethylamine then builds up and is released in the person's sweat,urine, and breath, giving off a strong fishy odor or strong body odor.Other names: Mal fish odor smell from sweating, Bromhidrosis and fishodor syndrome and osmidrosis.

Odor of skin in men to a large extend determined by apocrine glandssecretion. Sebeceous glands secretions have some odor also.Decomposition of keratinization especially in the presence ofhyperhidrosis produces offensive smell. Eccrine gland secretion isodorless but various substances may be excreted in it for examplegarlic.

Characteristic odors may be associated with various uncommonamino-acidurias; trimethyl-aminuria gives rise to the fish odorsyndrome. This odor is unpleasant and people avoid sitting near suchpersons.

The pharmacological compositions of this invention act as a deodorant byrendering the application area anhidrotic. As it suppresses the sweatsecretion of both apocrine and eccrine sweat gland it also suppressessebaceous gland secretion sebum. It also prevents bacterial activitywhich decomposes and liberates fatty acids with its characteristicsmell. The pharmacological compositions of this invention were used by30 patients and the composition was efficacious.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Vaginal Mal Fish Odor

The pharmacological compositions of this invention may also be used fortreating vaginal mal fish odor. This is the commonest form of vaginitis.The patient complains of an excessive grey, thin discharge associatedwith a fishy odor. This disorder is associated with infection by aerobicGram negative rod known as Gardnerella vaginitis. This organism alone isincapable of causing infection and now specific vaginitis is nowregarded as complex interrelationship between gardnerella and anaerobicspecies of bacteria of which genus mobiluncus have been identified onlyand their over growth within the vagina give increase in secretion andfishy mal odor.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Mal Fish Odor from Mouth

Mal fish odor from mouth and nose is a bad and unpleasant smell from themouth and nose.

The preferred treatment is with a topical pharmacological composition ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Morphoea

The pharmacological compositions of this invention may also be used fortreating Morphoea (Sclerosis of skin). Morphea is a medical term forlocalized scleroderma. The disease involves isolated patches of hardenedskin—there generally is no internal organ involvement. The condition maybe subdivided clinically into many types. In this disease skin becomethickened, elastic tissue is reduced and the skin becomes hard. Thesurface is usually smooth and the wrinkles in the skin are lost. Facialexpressions may also be lost.

The pharmacological compositions of this invention when topicallyapplied cause resolution of such cases with excellent results.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. From 1% to 2% salicylic acid and/or 0.025% to 0.05% clobetasolpropionate may be added to the pharmacological composition.

Hypermelanosis

The pharmacological compositions of this invention may also be used fortreating Hypermelanosis, a condition where there is excessive melanindeposition in the skin or in the oral mucous. This may be congenital oracquired through a drug reaction, melasma, addisions diseases,dyskeratosis congenital, post inflammatory hypermelanosis, berloquedermatitis, hypermelasnosis due to naevus of ITO, blue naevus,photodynamic and phototoxic reaction, hepatic cirrhosis (cause diffusepigmentation), amyloidosis, pellagra, Mongolian spots and etc.

The pharmacological compositions of this invention when locally appliedcures, diminishes or decreases such hypermelanotic pigmented spots.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Additionally, 0.025% to 0.05% clobetasol propionate and 2% to 3%salicylic acid may be added to the pharmacological composition.

Deformed Nails

The pharmacological compositions of this invention may also be used fortreating Deformed Nails. Such nails are either congenitally or acquiredthrough activity and environment. Without limiting the scope of theinvention, there are several type nail deformities:

-   -   1. Habit deformity—the deformity consists of a depression down        the center of one nail.    -   2. Splitting into layers—the tips of the nails split into layers        and pieces may flake.    -   3. Onychogryphosis—the nail become curved like a ram's horn.    -   4. Beau's lines—a transverse depression in nails.    -   5. Regular pitting-Excess ridging with or without pitting.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Nail Growth

The pharmacological compositions of this invention may be used toenhance the growth of nails which are broken before attaining its normallength.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Hair Fall and Alopecia

The pharmacological compositions of this invention may also be used foreffectively treating Hair Fall and Alopecia.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 5% mixture of sodium oxalate and oxalicacid. Optionally, 1.5% salicylic acid, 3% benzoic acid and 0.025%clobetasol propionate may be added.

Rosacea.

The pharmacological compositions of this invention may also be used fortreating Rosacea. Rosecea is a chronic skin disorder, usually affectingthe convexities of the face and characterized by redness of the skin,telengiectasia and episodes of inflammation. During an attack ofinflammation the effected skin typically develops papules, pustules andswelling. The disease is common at ages 30-50 years old. The disease isalso prominent in women.

Cardinal physical signs include 1) Erythema 2) Talengiectasia 3) Papules4) Swelling 5) Pustules. The pharmacological compositions of thisinvention when therapeutically and locally applied reduce inflammation,anti-erythematic and keratolytic activity and reduce the number ofepisodes.

The preferred treatment is with topical pharmacological compositions ofa 1% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 1% to 5% mixture of sodium oxalate and oxalicacid. Additionally, optionally 5% to 10% zinc oxide may be added as sunscreening agent and also as to prevent irritation to the composition.

Acne

The pharmacological compositions of this invention may also be used fortreating acne. All types of acne may be treated.

Acne is chronic inflammatory disease affecting more than 80% ofadolescents and may continue through adulthood. Some individuals sufferfrom acne into the thirties and even beyond. Lesion acne is mostfrequently found on face, neck and back, chest, shoulders and upperarms. Acne is characterized by the formation of comedones, papules,pustules, less frequently nodules or cyst and in some cases scarring. Apeak of incidents is usually between 14 to 19 years. Four major factorsin its pathogenesis

Increased Sebum Production

1) Keratinization of pilosebeceous duct

2) Abnormality of microbial flora

3) Production of inflammation

4) Hydration

The pharmacological composition of this invention when therapeuticallylocally applied inhibits sebum secretion and also inhibits sweat glandsecretion and provides an anhidrotic skin area. The pharmacologicalcompositions of this invention also have mild karatolytic activity anddiminish keratinization. The antibiotic properties provide a sterilesurface preventing or minimizing causative bacteria p-acne, as well asmicrobial flora. The composition also acts as an anti-inflammatory.

The preferred treatment is with a topical pharmacological composition ofa 1% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 1% to 5% mixture of sodium oxalate and oxalicacid. Optionally, 1% to 2% salicylic acid may be added. In severeconditions 0.5% to 1% hydrocortisone may be added for a short period oftime. A widely used treatment for cystic acne is direct local injectioninto the cyst, which is very painful and may cause leocoderma on theskin, i.e., the skin becomes depigmented. With the treatment describedherein, the cystic acne is treated with 2% to 5% of the pharmacologicalcomposition along with 0.025% to 0.05% Clobetasol propionate in suitableoil free cream applied locally. Such a treatment provides excellentresults to dissolve cyst.

Pityriasis Rosea

The pharmacological compositions of this invention may also be used fortreating Pityriasis rosea. Pityriasis rosea is an acute andself-limiting disease. The exact cause of the skin condition is unknown,probably infective in origin, affecting mainly children and young adultsand characterized by distinctive skin eruption and minimalconstitutional symptoms. Pityriasis rosea eruption has been associatedwith drugs such as arsenic, bismith, gold, captopril, ketototifen, etc.The eruption of Pityriasis Rosea follows a distinctive and remarkablyconstant pattern. Lesions are defined bright red, round or oval plaque,soon covered by fine scales. Lesions erupt in crops.

The pharmacological compositions of this invention when topicallyapplied locally, the skin lesions subside within five to fifteen days.It is theorized that the mechanism of its action is keratolytic andanti-bacterial.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 5% mixture of sodium oxalate and oxalicacid. Optionally, 1% to 2% salicylic acid may be added.

Psoriasis

The pharmacological compositions of this invention may also be used fortreating Psoriasis. Psoriasis is a genetically determined inflammatoryand proliferative disease of skin, most characteristic lesionsconsisting of chronic, sharply demarcated, dull red scaly plaques.Provocative factors involved trauma, infection, sun light, metabolicfactor drugs and etc.

The preferred treatment is with a topical pharmacological composition ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate may be added.

Lichen Planus

The pharmacological compositions of this invention may also be used fortreating Lichen planus. Lichen planus is an immunologically mediateddisease. Commonly presented as a skin lesion that is shiny, polygonaland violates papules. The lesion varies in size from a pin point to acentimeter or more and may be closely aggregated or widely dispersed. Onthe surface there may be Wickham's striae. Buccal mucosa and the tongueare most often involved but the anus and genitalia may also be involved.Lichenoid drug eruptions may occur due to certain drugs, for example,mepacrine, isoniazid.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate may be added. An oral composition may also be usedfor treatment.

Seborrhoeic Dermatitis

The pharmacological compositions of this invention may also be used fortreating Seborrhoeic Dermatitis. It is a chronic dermatitischaracterized by distinctive morphology including red sharply marginatedlesions covered with greasy looking scales and a distinctivedistribution in areas with a rich supply sebaceous glands namely thescalp, face and upper trunk. Dandruff appears to be the precursor ofseborrhoeic dermatitis. The yeast Malassezia furfur is increased inseborrhoeic dermatitis. P. ovale is also found.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate may be added.

Tinea

The pharmacological compositions of this invention may also be used fortreating Tinea (Fungal Infections). The present compositions aresuitable as broad spectrum, topical antifungal preparations for thetreatment oaf variety of fungal infections that may develop on the skinand nails, or which may be present and viable on surfaces which may comein contact with skin and nails. As a result, the compositions of thepresent invention may be used either therapeutically to treat apre-existing infection, or as a fungicidal disinfectant to cleansesurfaces that may harbor the fungus, thereby preventing or limiting theoccurrence of infections. The compositions are used to topically treatfungal infections that may develop on the skin (dermatomycoses) as wellas toe and finger nails (onychomycosis). These fungal infections, alsocommonly known as Tinea pedis (athlete's foot), Tinea unguium (nailinfections), Tinea cruris, Tinea corporis, Tinea versicolor andcandidiasis, among others, are caused by different types of fungus suchas those of the gena Trichophyton, Epidermophyfon, Microsporum andCandida.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 5% mixture of sodium oxalate and oxalicacid. Optionally 1% to 2% salicylic acid, 5% to 10% zinc oxide may beadded. An oral composition may also be used for treatment.

Oral Submucous Fibrosis

The pharmacological compositions of this invention may also be used fortreating Oral Sub mucous Fibrosis. This disease can follow burns,irradiation but commonly and particularly this disease occurs due tohabit of chewing of betel-nut which predisposed to oral sub mucusfibrosis. In such condition there is loss of elasticity of oral tissues.This disease is particularly found in Indian sub-continent.Pathologically there is fibrosis extending to sub mucosa and muscles.Epithelial changes included atrophy to keratosis. This disease, whensevere, restricts the mouth from opening. The patient is unable to eatand even talk properly. This disease may transform into squamous cellcarcinoma. Management of this disease is very difficult. Onlyintralesional corticosteroids injection locally has been found to help,otherwise surgery is needed. The pharmacological compositions of thisinvention when applied locally in a cream or in a jelly form haveexcellent (almost 100%) beneficial effect, resulting in the patientbeing able to reopen his/her of mouth to a large extent. Twenty-five(25) patients who were habitual chewers of the betel nut were thepatients.

The preferred treatment is with a topical pharmacological compositionsof a 2% to 10% (by weight) of a mixture of sodium citrate and citricacid or, alternatively with a 2% to 10% mixture of sodium oxalate andoxalic acid.

Amyloidosis

The pharmacological compositions of this invention may also be used fortreating Amyloidosis. Amyloidosis is a disease in which there is adeposition of a proteinous substances composed of one of family ofbiochemically unrelated proteins which is associated with considerabledysfunction. Amyloid deposits also contain extra cellular matrixcomponent including glycosaminoglycans and proteoglycans which may beinvolved in pathogenesis.

The pharmacological compositions of this invention were tested onpapular (lichen) amyloidosis and upon macular amyloidosis in 24 patientsand found to be effective.

Amyloidosis is classified as follows:

1) Primarily localized cutaneous Amyloidosis

2) Secondarily localized cutaneous Amyloidosis

3) Systemic Amyloidosis

The pharmacological compositions of this invention are used totherapeutically treat skin (cutaneous) amyloidosis whatever the cause.My invention only treats and treated with success all skin conditions,where there is deposition of amyloid.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate may be added.

Purpura

The pharmacological compositions of this invention may also be used fortreating Purpura. Purpura is discoloration of skin or mucous membranesdue to extra extravasations of red blood cells due to many causes. Theskin becomes purpuric. Purpura may be caused by raised intravascularpressure. There are several types, e.g., senile purpura, corticosteroidpurpura, drug purpura, contact purpura, schamberg purpura, coagulationdefects purpura and etc.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally, 0.025% to 0.05 clobetasol propionate may be added tothe pharmacological composition.

Discoid Lupus Erythematosus.

The pharmacological compositions of this invention may also be used fortreating Discoid lupus erythematosus. This disease is an autoimmunedisease characterized by eruption of scaly patches atrophy, scarring andpigmentary changes, and most frequently involving the face. The diseaseaffects twice as many females as males.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate may be added.

Contact Dermatitis

The pharmacological compositions of this invention may also be used fortreating Contact dermatitis. Any antigen that comes in contact with skinmay react with the skin causing contact dermatitis. It may be eitherprimary irritant contact dermatitis or primary allergic contactdermatitis. For example, there is shoe dermatitis, hair dye contactdermatitis, nickel dermatitis, washing powder dermatitis, etc. The skinbecomes scaly, pigmented and itchy and in some cases oozing.

The preferred treatment is with topical pharmacological compositions ofa 1% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 1% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid and/or 0.025% to 0.05%clobetasol propionate and 5% to 10% zinc oxide may be added as for sunscreening agent and also for as soothing effect.

Hair and Skin Shiner

The pharmacological compositions of this invention may also be used as ahair and skin shiner. The compositions make the hair and skin shine,reflect the light causing an attractive look. This invention may beincorporated in shampoo and in face cream.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid.

Mollascum Contagious.

The pharmacological compositions of this invention may also be used fortreating Mollascum contagious. This is viral infection of skin caused byan unclassified member of poxviridae in Mollascum contagiousam lesion,characterized by papules and nodules. Its general treatment includedcryotherapy, squeezing its forceps (a painful procedure), application ofsilver nitrate or phenol with stick and etc.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 10% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid may be added.

Herpes Simplex

The pharmacological compositions of this invention may also be used fortreating Herpes simplex. This is viral infection is caused by herpesvirus hominis (herpes simplex virus, HSV). It is a common infection inmen. Skin shows vesicles presenting as white plaques are present. Skin,tongue, buccal mucous membrane, palate, genital area and etc. areinvolved.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 5% mixture of sodium oxalate and oxalicacid. Optionally 1% to 2% salicylic acid and 5% to 10% zinc oxide may beadded.

Paronychia

The pharmacological compositions of this invention may also be used fortreating Paronychia. Paronychia is a painful full swelling of nailfolds. It commonly occurs in persons whose hands are excessively exposedto water. It may result from local injuries for example nail biting,splits or there may be no preceding injuries. It is a common complaintand is usually due to bacterial infection including staphylococcal,other organisms involved in it may be streptococci, pseudomonas, Proteusvulgars and it may also be due to other causes for example fungalinfection, Candida albicans infection, etc.

The preferred treatment is with topical pharmacological compositions ofa 2% to 5% (by weight) of a mixture of sodium citrate and citric acidor, alternatively with a 2% to 5% mixture of sodium oxalate and oxalicacid. Optionally 2% to 4% salicylic acid may be added.

EXAMPLES

Preparation Active Composition

An equal amount of pharmaceutical grade sodium bicarbonate and citricacid by weight was placed in a sterile plastic container in an open roomwith a temperature at about 25 degree Celsius. The composition was mixeduntil a uniform mass was formed. A sufficient amount of purified sterilewater was poured slowly into the mass to allow the reaction of sodiumbicarbonate and citric acid. The mixture was left standing for 24 hoursto allow the water and carbon dioxide to evaporate and for the productto dry. The mixture was again stirred to allow carbon dioxide and watervapors to further escape. A white crystalline and odorless powder wasobtained. The final product contained 87% sodium Citrate and 13% citricacid as active ingredients. The measured pH of final product was 6. Thissolid composition was crushed and ground to a fine powder to produce anactive composition that was pharmaceutically and physiologicallyacceptable, hereinafter the “pharmacological composition”.

Sodium Citrate—Citric Acid Mixture

Stoichiometric Formulation Ratio:

Method of Producing Active Composition:

Chemical Equation with Structural Formulas:

Structural formulae of Active ingredients:

In Vitro Study

Summary:

The goal was to determine the susceptibility and activity of thepowdered pharmacological composition produced on different bacterialstrains at different concentration. The composition was a mixture ofsodium citrate (stoichiometric ratio) and citric acid with thepercentage of sodium citrate 87% and citric acid 13%,

The procedure was to apply the powdered pharmacological composition ofsodium citrate and citric acid to infectious bacterial strains and todetermine susceptibility and activity of the pharmacological compositionas anti-bacterial agent.

1. Material & Method:

Different infectious bacterial strains from different infected siteswere selected, including pathogenic gram positive and gram negativebacterial strains. The activity of the powdered pharmacologicalcomposition on different bacterial strains was determined by applying itat different concentrations on various strains. In this studysignificant antimicrobial was observed when we used 300 mg and 500 mg ofthe pharmacological composition in dry powdered form.

The powdered pharmacological composition, i.e., a mixture of sodiumcitrate and citric acid with the percentage of sodium citrate 87% andcitric acid 13%, was applied to infectious bacterial strains, includingGram Positive Organism (Staphylococcus aureus Streptococcus species andStreptococcus Gp D) and gram negative bacteria (E. toll, Klebsiellaspecies, Moragnella species, Enterobacter species, Serratia species,Salmonella typhi, Proteus species) to determine susceptibility toanti-microbial activity of the composition.

A wire loop method was used to inoculate the bacteria on media plates.MacConkey Agar (Merck, Germany) was used for culturing of gram negativeorganism and blood Agar Media (Oxoid, England) was used for culturingthe gram Positive Organism. For Confirmation and Identification of theorganism, biochemical tests were done. For gram Negative Organism weused Triple Sugar Iron Media (Oxoid, England), Citrate Agar (Merck,Germany) Sulphide Indole motility media (Merck, Germany) Urea Agar(Oxoid, England) and for Gram Positive Organism we used Catalase test,Novabisin disk and manitol Salt Agar for Identification ofStaphylococcus aureus and we also performed tube Coagulase test and forStreptococcus we did gram staining and Catalase test (showed negativeResult).

2. Anti-Microbial Susceptibility Testing

A. The Gram Positive Organism Tested:

-   -   Staphylococcus aureus.    -   Streptococcus species.    -   Streptococcus gp D.

B. The Gram Negative Organism Tested:

1. Lactose Fermenting Bacteria:

-   -   E. coli.    -   Klebsiella species    -   Enterobacter species

2. Non-Lactose Fermenting Bacteria:

-   -   Pseudomonas aeruginosa.    -   Proteus species    -   Morganella species.    -   Serratia species.    -   Salmonella species.    -   In the present study anti-microbial susceptibility testing was        done on Mueller Hinton Agar (Oxoid, England) using disk        diffusion (Kirby Bauer's) technique. This method was done        according to Clinical and Laboratory Standards Institute (CLSI)        guideline to determine susceptibility of microbial agents.        Description:    -   The standard method used for determination of antimicrobial        susceptibility is the disk diffusion procedure of Macfarland        turbidity (Provided Powder used in replacement of disk)

Material Required:

-   -   Suitable agar & broth.    -   Provided Powder.    -   Sterile Cotton Swab.    -   Wire loop.    -   Medium: Mueller Hinton Agar (Oxoid, England)    -   Broth: Sterile peptone water (Oxoid, England)

Procedure:

-   -   Inoculum:    -   a) The inoculums were prepared by transferring a few identical        colonies of different organism from the primary growth of Gram        Negative (Pseudomonas aeruginosa, E. coli Klebsiella species,        Enterobacter species, Moragnella species, Proteus species,        Serratia species, Salmonella species) and Gram Positive        (Staphylococcus aureus, Streptococcus gp D and Streptococcus        species) with a wire loop in 2 ml of Peptone water (already        filled in Sterile tube).    -   b) Incubate the Suspension at 35° C. for 10-15 minutes.    -   c) A sterile Swab applicator was dipped into the Culture        Suspension. Excess suspension was removed by rotating it against        side wall of tube, then streak on entire surface of medium in 3        different directions, by rotating the plate at 60° C. angle.

Placement of Pharmacological Composition (Antimicrobial Agent) (Powder)at Different Conditions and Concentrations:

After Streaking, the inoculum was allowed to dry for at least 5 minutesand inoculated with the powdered composition.

-   -   Pharmacological composition (antimicrobial agent) powder was        applied: (50 mg)

For Staphylococcus (Resistant Strain and Sensitive strain: 2 strainsused), Streptococcus gpD Streptococcus species, Pseudomonas aeruginosa,E. coli Klebsiella species, Serratia species, Morganella species, andProteus species)

-   -   Pharmacological composition (antimicrobial agent) powder was        applied: (500 mg)

For Klebsiella species, E. coli, Streptococcus species, Pseudomonasaeruginosa, Staphylococcus aureus Serratia species, Morganella species,Enterobacter species and Proteus species.

-   -   Pharmacological composition (antimicrobial agent) powder was        applied: (300 mg)

For Klebsiella Species, and different strains of E. coli.

-   -   The same procedure was used for 1000 mg        Incubation:

After the direct placement of the pharmacological composition(antimicrobial agent) was applied (50 mg) the concentrated disk onMueller Hinton plates should be incubated aerobically at 35° C. forovernight.

Precautions:

For the proper interpretation of the results:

1. The suspension should always be made from pure culture and not frommixed culture.

2. The size of inoculum is uniform (avoid heavy/light inoculum).

3. The incubation condition must be of appropriate temperature andatmosphere.

4. The depth of the medium 4 mm (Approx. 25 ml medium in 100 mm plate)

5. The incubation period should not be less than 8 hrs. or more than 24hrs.

Results:

In this study the organism showed different activities.

TABLE 1 Direct Antimicrobial Agent (Powder) applied at 50 mg Experiment.Used Quantity of Bacteria antimicrobial agent Result. Gram PositiveBacteria: Staphylococcus aureus Strain 1 50 mg Showed Activity Strain 250 mg Showed Activity Streptococcus gp D 50 mg No-Activity ObservedStreptococcus species 50 mg No-Activity Observed Gram Negative Bacteria:E. coli 50 mg No-Activity Observed Klebsiella species 50 mg No-ActivityObserved Serratia, species 50 mg No-Activity Observed Morganella species50 mg No-Activity Observed Proteus species 50 mg No-Activity ObservedPseudomonas aeruginosa 50 mg No-Activity Observed

TABLE 2 Direct Antimicrobial Agent (Powder) applied at 500 mg. Zone ofUsed Quantity of inhibition Bacteria antimicrobial agent Result SizeGram Positive Bacteria: Staphylococcus 500 mg Showed Activity 22 mmAureus Streptococcus 500 mg Low effect — species showed Gram NegativeBacteria: E. coli 500 mg Showed Activity 25 mm Klebsiella species 500 mgShowed Activity 28 mm Pseudomonas 500 mg Showed Activity 43 mmaeruginosa Serratia species 500 mg Showed Activity 30 mm Morganellaspecies 500 mg Showed Activity 30 mm Enterobacter 500 mg Showed Activity28 mm species Proteus species 500 mg Showed Activity 25 mm *Zone sizeshowed variation due to use of dry loose form of powder.

TABLE 3 Direct Antimicrobial Agent (Powder) applied at 300 mg. Quantityof antimicrobial Zone of Bacteria agent Result. Inhibition Size GramNegative Bacteria: E. coli 300 mg Showed Activity 45 mm Klebsiellaspecies 300 mg Showed Activity 35 mm *Used different strains in of E.coli and Klebsiella species in Table 2 & 3Discussion:

This study demonstrates the activity of the powdered anti-microbialagent, i.e., the pharmacological composition, against micro-organisms.This microbial agent (powder) or pharmacological composition also workedagainst those organisms which are normally highly resistant againstother antimicrobial agents. Those organisms include Pseudomonasaeruginosa, Staphylococcus aureus, Streptococcus gp D.

In the first set of tests we applied the antimicrobial agent, i.e.,pharmacological composition, in very low quantities (50 mg). Minimalactivity was observed against Gram Positive (Staphylococcus aureusStreptococcus gp D Streptococcus species) and Gram Negative Strains(Pseudomonas aeruginosa, E. coli Klebsiella species, Serratia species,Moragnella species, Proteus species).

In the second set of tests condition we increased the quantity ofantimicrobial agent (powder)—pharmacological composition—to 500 mgquantity of the powder which showed activity against bacteria GramPositive bacteria (Staphylococcus aureus Streptococcy species) and GramNegative bacteria (Klebsiella species, E. coli Pseudomonas aeruginosa,Serratia species, Moragnella species, Proteus species, Enterobacterspecies).

In the third set of tests we used different strains of Klebsiellaspecies and E. coli and applied 300 mg antimicrobial agent(powder)—pharmacological composition—which showed activity against thosebacterial strains.

Conclusions:

In this study minimal activity was observed after applying 50 mg of theanti-microbial agent. Significant zone sizes of inhibition were observedwhen the pharmacological composition was applied directly at 500 mg and300 mg potency in powdered form.

It is believed that the mode of action of the pharmacologicalcomposition is to inhibit, topoisomerase enzyme which inhibits bacterialcell replication.

Clinical Trials Oral Treatment of Bacterial Infection

I applied the pharmacological composition as anti-bacterial agent innumerous patients. The pharmacological composition contained 87% sodiumCitrate and 13% citric acid as active ingredients. The measured pH ofthe final product was 6. This solid composition was crushed and groundto a fine powder to produce an active composition that waspharmaceutically and physiologically acceptable, hereinafter the“pharmacological composition” and then encapsulated, hereinafter theencapsulated pharmacological composition. Included herein are exemplaryresults from ten (10) patients.

Oral Application of Pharmacological Composition:

Patient A Gender Male Age 28 years Diagnosis Typhoid

Present Complaint:

Patient complains of fever for the past week. Patient states that thefever fluctuates between highs and lows, and sometimes remains low butit does not reach normal. The patient is lethargic and feels week.Patient has also complained of abdominal pain for the past two days.

Examination:

His fever is 99° F.; blood pressure is 120/70 mm of Hg. A Typhidot testfor typhoid was positive, ESR 55 mm/hr., CBC (complete Blood Picture)report shows Hb 9.5 g/dl, TLC 14×10⁹/L, Blood Culture report showssalmonella typhoid. Typhoid fever is confirmed.

Treatment:

The patient was given 500 mg of encapsulated pharmacological compositionthrice daily and advice to take half an hour after food and revisitafter 5 days.

Second Visit:

Patient visited five days after initial visit to state that his feversubsided but not completely. The patient also said that his overallcondition has improved. Patient was given same 500 mg encapsulatedpharmacological composition and advised to continue to take thrice a dayand revisit after five days.

Third Visit:

Patient revisited five days after the previous date and indicated thathis fever had completely subsided and that his weakness and otherillness like condition had also subsided. The patient was told to repeatthe same treatment of 500 mg of the encapsulated pharmacologicalcomposition thrice a day and advised to complete the therapy for furtherfive days and then revisit for a blood culture and sensitivity report.

Fourth Visit:

The patient was seen nine days after the Third Visit with completesatisfaction, as there is neither fever nor any other illness likecondition. A blood culture and sensitivity report showed no bacterialgrowth. All treatment was stopped.

Patient B

Age 31 years

Gender: Female

Diagnosis: Tonsillitis

Present Complaint:

Patient complained that she was suffering from severe tonsillitis for 15days. The patient complained of severe pain, itching, and irritation inthroat. She developed hoarseness of voice. The patient said that she hadchronic history of tonsillitis for the last 8 years. The conditionremained off and on. When she developed a severity in her disease aconsultant advised her broad spectrum antibiotic injection. Aftergetting injections for at least 15 days, she obtained relief for 1 to 2months.

Examination:

Her throat was severely inflamed and there were enlarged tonsils withpustules with oozing purulent pus. The tonsils are grossly inflamed.

Treatment:

The patient is given 500 mg of the encapsulated pharmacologicalcomposition twice a day and advised to return after 5 days.

Second Visit:

Patient visited 5 days after her previous visit. Her tonsillitis andother inflammatory condition were reduced by about up to 50%. Thepatient was again advised to continue 500 mg encapsulatedpharmacological composition twice a day and revisit after 5 days.

Third Visit:

The patient visited 5 days after her previous visit. Her severeinflammatory condition and severe tonsillitis signs and symptoms werealmost totally subsided; her hoarseness of voice and other complaintsalso subsided. To be on the safe side, the patient was again advised tocontinue 500 mg capsules twice daily for 5 days more since she had beensuffering in this disease for the last 8 years. After taking this lastdose she was told there was no need for additional visits unless she hadcomplaints.

Fourth Visit:

Patient visited 6 months after her last visit and was very happy andsaying that after every 2 to 3 months she used to develop tonsillitisand used to get antibiotic injections. She has not developed tonsillitisher last treatment.

Patient: C

Age; 42 years

Gender; female

Diagnosis; UTI

Present Complaint:

Patient complains of burning micturition for the last 10 days.

Examination:

Patient looked ill and appears to be tense and have 99° F. fever. Adetailed report on urine shows pus cells 15-20/field and culture andsensitivity report shows growth of E. coli.

Treatment:

Patient was told to take 500 mg of encapsulated pharmacologicalcomposition twice a day and advised to revisit after 5 days.

Second Visit:

Patient visited 5 days after the previous date and said that now she isfeeling relief and now there is no burning micturition. Patient wasadvised to continue 500 mg encapsulated pharmacological composition foran additional 5 days and at the end of 5th day come with investigationreport of urine detailed report on culture and sensitivity.

Third Visit:

Patient visited 8 days after her last visit and said she was satisfiedand that there no burning micturition, fever or other complaints. Herurine report showed no bacterial growth. Her treatment was stopped.

Patient: D

Age: 55 years

Gender: female

Diagnosis:

Cholecystitis

Present Complaints:

Patient complained of severe pain in right hypochondrium region for 8days. Upon examination of investigations report, ESR 49. Ultrasound ofupper abdomen shows cholecystitis and cholelithiasis

Examination:

Patient looked tense and anxious. Patient complained of nausea andvomiting. Upon examination of abdomen there was tenderness on the righthypochondrium.

Recommendations:

Patient was advised to take 500 mg encapsulated pharmacologicalcomposition twice a day and revisit after 5 days.

Second Visit:

Patient visited 5 days after previous visit and said there was relief inher pain and the nausea and vomiting had subsided. Patient was advisedto continue the same remedy and dose for an additional 5 days.

Third Visit:

Patient visited 5 days after the previous visit with complete relief inpain, nausea, vomiting and others sign and symptoms. Patient is againtold to do the same treatment as previously, 500 mg encapsulatedpharmacological composition for an additional 5 days to be on the safeside and advised to revisit after 5 days with an ultra sound report.

Fourth Visit:

Patient visited 5 days after previous visit with ultra sound reportwhich was normal, without cholecystitis. The treatment was stopped.

Patient: E

Age: 50 years

Gender: male

Diagnosis:

Carbuncle

Complaint:

Patient had a case of diabetes mellitus since 12 years and is onanti-Diabetic treatment. Twenty days prior to his visit he developed anodule on the back of his neck which was gradually increasing in sizeand acquired big area and which started oozing and later on there waspus discharging from multiple orifices and severe pain.

Examination:

There was a big lesion with multiple orifices with pus discharge andmarked inflammation.

Investigation Report:

Shows high side Fasting and Random blood sugar.

Recommendations:

Patient was given 500 mg 500 mg encapsulated pharmacological compositionto take four times a day half an hour after food and advised to revisitafter 5 days.

Second Visit:

Patient's lesions were improved and there was a declination ininflammation, oozing and pus discharge. The patient had achieved somerelief. The patient was advised to continue the same treatment of 500 mgencapsulated pharmacological composition four times a day and wasadvised to revisit after 5 days

Third Visit:

The patient visited 5 days after the previous visit and was greatlysatisfied. There was a remarkable declination of the lesion area,remarkable declination in oozing and pus discharge and the inflammatorycondition. The patient had achieved some relief. The patient was advisedto continue the same treatment of 500 mg encapsulated pharmacologicalcomposition three times a day and was advised to revisit after 5 days.

Fourth Visit:

Patient visited 5 days after the previous visit and was fully satisfied.Upon examination the lesion was completely cure. There was noinflammatory condition, oozing or pus discharge. There remained only avery peanut size dried nodule. To be on the safe side The patient wasadvised to continue the same treatment of 500 mg encapsulatedpharmacological composition three times a day and for 5 days and advisedthat he need not return but to get proper treatment for the diabeticmellitus, as he was cured now.

Patient F

Gender: male

Age: 12 years

Diagnosis:

Chalazion

Complaint:

small, soft reddish nodule on right upper inner lid with slight pain andpus discharge for 10 days. He received treatment in the past, but therewas no relief. Examination: There was a markedly inflammatory softpeanut size nodule with slightly discharging purulent pus on right upperinner side of lid with conjunctivitis eye.

Recommendations:

Patient was given 250 mg the crushed and ground pharmacologicalcomposition containing 87% sodium citrate and 13% citric acid in neutralsyrup thrice a day half an hour after food and was advised to revisitafter 5 days.

Second Visit:

Patient visited 5 days after previous visit and his mother said that hehas obtained substantial relief, the lesion was reduced and the rednessin his eye also declined. Upon examination the nodule was reduced, pusdischarge had ceased, and the conjunctivitis was in decline. The patientwas advised to repeat the treatment for another 5 days, i.e., 250 mg thecrushed and ground pharmacological composition containing 87% sodiumcitrate and 13% citric acid in a neutral syrup thrice a day half an hourafter food and was advised to revisit after 5 days.

Third Visit:

The patient visited 5 days after previous visit and was satisfied. Therewas no complaint of pain, redness, nodule, discharging pus, orconjunctivitis in eye. There appeared to be a remnant of a lesion. Thepatient was given same remedy with same dose for an additional 5 days tobe on safe side, advised to stop treatment after that and that there wasno need to visit again because you are cured.

Patient G

Gender Female

Age 36 years

Rx Paronychia

Complaint:

Patient complains of pain, swelling and pus discharge from the nail foldof right index finger for about one week.

Examination:

There was swelling and purulent pus discharge and an inflammatorycondition. The case was diagnosed as Paronychia.

Recommendations:

Patient was given 500 mg encapsulated pharmacological composition twicea day and advised to revisit after 5 days.

Second Visit:

Patient visited 5 days after previous visit and had achieved more than75% relief. Upon examination the swelling, discharging pus, inflammatorycondition and pain had subsided to a large extent. Patient was given 500mg encapsulated pharmacological composition twice a day and advised torevisit after 5 days.

Third Visit:

Patient visited 5 days after the previous visit and was fully satisfiedas there were neither complaints of pain. Upon examination there was noswelling, pus discharge or inflammatory lesions. The patient wascompletely cured and treatment was stopped

Patient: H

Gender: Male

Age: 52 years

Diagnosis:

Acute exacerbation of chronic bronchitis.

Complaints:

Patient complained of a history of chronic bronchitis for the last threeyears where he gets attacks of fever and severe attacks of cough withpurulent sputum and preventing him from obtaining sleep for the pastyear. He has a history smoking for thirty years. Two months ago thesymptoms were not present but as the weather changed he has againdeveloped fever, cough with purulent sputum for the last week. He wastold that he has an acute exacerbation of chronic bronchitis.

Examination:

Patient had a fever, on auscultation there is wheezing and crepitationon chest.

Recommendations: Patient was given 500 mg encapsulated pharmacologicalcomposition four times a day half an hour after food and advised torevisit after five days.

Second Visit:

Patient revisited five days after previous visit and says that heobtained some relief but still has a cough with purulent sputum. He wasstill running a fever but the temperature slightly subsided. Patient wasagain given 500 mg encapsulated pharmacological composition four times aday half an hour after food and advised to revisit after five days.

Third Visit:

Patient visited five days after the previous visit and was highlysatisfied in that he had obtained much greater relief and there was nofever. However, his cough and purulent sputum had only somewhatsubsided, but now sleeps deeply and comfortably. Patient now complainedof dizziness and was given anti-motion therapy. Patient was again given500 mg encapsulated pharmacological composition three times a day halfan hour after food and advised to revisit after five days.

Fourth Visit:

The patient visited five days after previous visit with fullsatisfaction and says that now he was in relief and there was no fever,cough or sputum nor complaint of dizziness after taking anti-motiondrug. To be on the safe side the patient is again given same 500 mgencapsulated pharmacological composition but now only twice a day for anadditional five days and then stop treatment for he is now cured.

Patient: I

Gender: female

Age: 25 years

Diagnosis:

cellulitis (skin and soft tissue infections)

Complaint:

Patient is 24 weeks pregnant and complains redness and pain on upperfront of left thigh and also complains of fever for past five days.

Examination:

There was redness and an inflammatory condition on the front of leftthigh. On touching the lesion, it was warm and tender and there wastenderness.

Recommendations:

The patient was given 500 mg encapsulated pharmacological compositiontwice a day, half an hour after food and advised to revisit after fivedays.

Second Visit:

Patient visited five days after previous visit with declination oflesion and inflammation tenderness. Her fever had subsided. The patienthad complained of slight nausea and vomiting. The patient was given 500mg encapsulated pharmacological composition twice a day, half an hourafter food. She was also given nausea and vomiting anti-emetic drug.Patient was advised to revisit after five days.

Third Visit:

Patient visited five days after previous visit with marked declinationof signs and symptoms. There was no fever, tenderness, pain orinflammatory condition. There was still a complaint of nausea andvomiting and she was given anti-emetic. Patient for safety was advisedto repeat the 500 mg encapsulated pharmacological composition twice aday, half an hour after food for an additional five days to reduce allsigns and symptoms.

Patient: J

Gender: male

Age: 16 years

Diagnosis:

Sub acute appendicitis

Complaints:

Patient complained of an on and off pain in right hypochondrium for thelast three days. The patient also complained of nausea with episodes ofpain. The patient also complained of fever for the past three days.Patient also complained of the same symptoms twenty days back.

Examination:

There was tenderness on the right hypochondrium and there was a lowgrade fever also.

Recommendations:

The patient was given 500 mg encapsulated pharmacological compositiontwice a day, half an hour after food and advised to revisit after fivedays.

Second Visit:

The patient revisited five days after previous visit. The signs andsymptoms had subsided. Upon examination there was less tenderness andthere was also no fever. The patient was given 500 mg encapsulatedpharmacological composition twice a day, half an hour after food andadvised to revisit after five days. The patient was also advised toconsult a General Surgeon for his opinion because the appendix mightburst, which might cause peritonitis and poisoning with a fatal outcome.The therapy recommended herein reduced all signs and symptoms and hadarrested the growth of bacteria, reducing inflammation.

Third Visit:

Patient revisited five days after previous visit with completesatisfaction. All signs and symptoms were reduced. The surgeon advisedthat if he again feels severe pain than he will operate to remove theappendix. If there are no complaints there is no need to operate. Alltherapy stopped.

Side Effects and Drug Interaction Observed

No serious side effects were observed in any patients. The onlyside-effects observed, were nausea and vomiting and some dizziness inabout 0.5% of the patients. One in 500 patients developed a minorallergic reaction which subsided when treated with an anti-histaminedrug. There were no drug interactions noted with anti-coagulant drugs.No serious adverse effects were observed in patients or anylife-threatening conditions as Steven-Johnsons syndrome or anaphylacticshock with oral therapy.

EXAMPLES Treatment of Deformed Nails

An embodiment of this invention relates to ameliorating, preventingand/or treating nail deformity, slow nail growth/retardation due toeither systemic or local skin diseases. The pharmacological compositionsof this invention may be used to enhance the growth of nails which arebroken before attaining its normal length.

The preferred treatment is with topical pharmacological compositions ofa 2% to 10% (by weight) of a mixture of sodium oxalate and oxalic acid.The method of treatment of such nail growth symptoms comprises topicallyapplying to the nails a composition comprising a mixture of sodiumoxalate and oxalic acid with specific ratio by percentage, by weight anda physiologically acceptable carrier vehicle. The highly preferredcomposition is a mixture of 78.44% sodium oxalate and 21.56% oxalicacid. A preferred range is about 73% to about 83% Sodium oxalate andabout 17% to about 27% oxalic acid. It is to be understood however thatvarious weights and ratios of sodium oxalate and oxalic acid may be usedas long as a safe and efficacious pharmacological composition isproduced. Optionally, the composition applied consists of a mixture ofsodium oxalate and oxalic acid and an effective amount ofhydrocortisone, e.g., about 1% by weight of hydrocortisone.

The method of this invention is effective, low cost, and easily applied.The composition used is easy to manufacture as demonstrated herein andis effective in the treatment of deformed nails, e.g., nail diseases, toameliorate, prevent and/or treat such diseases.

The method for treating the deformed nails and nail diseases hereincomprises topically administering or applying a composition, comprisinga sodium oxalate and oxalic acid mixture with specific ratio by weightand percentage to the nails of a mammal, typically a human. Morespecifically, the method comprises applying a pharmacologicalcomposition to the patient's fingers or toe nails. The amount of thecomposition applied is a therapeutically effective amount of thecomposition that will ameliorate, prevent and treat naildiseases/deformed. The patient should avoid contacting his/her eyes withhis/her fingers after treatment.

Pharmaceutical Carrier

Examples of the pharmaceutical carrier and the method of preparationthat may be used are provided herein.

A. Oil and water base vehicle (base) preparation (100 grams on smallscale):

-   -   Vessel A—Take 75 grams purified and sterile water in suitable        container like stainless steel vessels and heat it to 70° C.    -   Vessel B—Take 25 gram of a pharmaceutical grade emulsifying wax        and melt it by heating up to 70° C. in a water bath.    -   Mix the heated water into heated emulsifying wax stirring slowly        until the mixture is uniform and the temperature of mixture        decreases to about 35° C. then cool. The pharmaceutical carrier        thus contains 25% emulsifying wax and 75% water by weight.        Pharmacological Composition

Composition A:

-   -   5% sodium oxalate and oxalic acid mixture incorporated in the        pharmaceutical carrier, i.e., 25% % emulsifying wax and 75%        water. Optionally, a preservative may be added.

Composition B:

-   -   5% sodium oxalate and oxalic acid mixture and 1% hydrocortisone        incorporated in the pharmaceutical carrier, i.e., 25% %        emulsifying wax and 75% water.

Treatment Procedures and Clinical Results Patient: A

Age: 36

Gender: Male

Status: Married, low socio-economic

History or Complaints of Patient:

Patient complains that his nails were normal with natural shape twoyears back, then gradually the nails began to develop pin head sizedepressions on nails surface of two nails. With the passage of time,gradually these depressions increased in other fingers nails also andwithin the period of 3 years, most of the nails have pin head sizedepressions. Patient does not give any history of depression in toenails

On Examination of Patients:

On examination of the patient, no existing lesions or signs were foundof any existing skin disease, although his skin appears to be dry. Therewas no history of any systemic disease or skin disease. On examinationof the nails of the fingers pitting was observed on most of his nailsbut there were no depressions (pitting on toes nails) except that hisall nails were rough and dry.

Diagnosis:

Diffused pitting on the finger nails.

Treatment and Advice:

Patient was given Remedy A and advised to apply it locally on theaffected nails twice a day and revisit after 20 days.

Patient 2^(nd) Visit:

Patient revisited 20 days after the first visit to say that his naildepressions were declining. On examination his pitting nails werefilling. The patient was given the same Remedy A to apply in the samemanner as previously and advised to revisit after 20 days.

Patient 3^(rd) Visit:

Patient visited one month after previous date. 75% of the nails pittingdepressions were filled. Patient was again given same Remedy A with theadvice to revisit after one month

Patient 4th Visit:

The patient visited one month after his previous visit and was quitehappy because all the nail depressions were substantially filled and hisnails were shining. On examination 90% of the pitting was filled. Thepatient was again given the same Remedy A and advised to revisit afterone month.

Patient 5^(th) Visit:

Patient revisited one month after the previous visit. All naildepressions were almost completely filled. Examination revealed thatapproximately all depressions had disappeared and the nails had lusterand were shining. The patient treatment was stopped and the patient wasadvised to keep his nails moisturized.

Patient: B

Age: 21

Gender: Female

Status: Unmarried, College student.

History or Complaints of Patient:

Patient complains of that her nails were fine 6 years ago when shedeveloped a depression in the middle of the right thumb nail whichgradually increased in size to form a canal like structure in the nail.Subsequently fine cracks extended from the canal like structure to theedges of the nail on each side.

On Examination of Patient:

On examination of all nails of the hands and feet only the right thumbnail shows a canal like depression and the cracks projecting towards andreaching the edges of the nail on each side. Her history did not revealany skin or systemic diseases.

Diagnosis:

median nail dystrophy of heller.

Treatment and Advice:

Patient was given Composition A and advised to apply locally twice a dayand revisit after one month.

Patient 2^(nd) Visit:

Patient visited one month after the first visit and said that canal andcracks are filling. On examination of the affected nail, canal andcracks were filled up to 40%. Patient was advised to revisit after onemonth again.

Patient 3^(rd) Visit:

Patient revisited one month after the previous visit and was very happyto say that she is getting cured and the canal and cracks are beingfilled. On examination there was 70% of filling of depressed nail. Thepatient was given the same Composition A and advised to revisit afterone month.

Patient 4th Visit:

Patient revisited one month after the previous visit. Her depressed nailcanal was substantially filled. On examination, there was 90% filling ofaffected nail. She was given again the same Composition A to apply insame manner as previous and advised to revisit after one month.

Patient 5^(th) Visit:

On her fifth visit one month after the previous visit the nail canal andcracks were filled completely filled. Treatment was stopped and she wasadvised to return in one year.

Patient 6^(th) Visit:

Patient came one year after the last visit. She was 100% cured as it wasat the time last attended. There were no developments of any canal orcracks.

Patient: C

Age: 12

Gender: Male

Status: Student of class 5, High socioeconomic

History or Complaints of Patient:

Mother of patient states that her son nails of fingers and toes do notgrow normally and does not increase in size as others grow. Shecomplains that these nails are not broken but have slow and limitedgrowth. She said that after 2 to 3 months, it grows slightly but growthis restricted.

On Examination of Patients:

On examination of patient, nails of child of hands and toes are belownormal growth. On examination of patient, there is no lesion in skinwhich could indicate any sign of skin disease. Mother does not give anyhistory of systemic disease except that patient appears to be anemic.

Diagnosis:

Slow rate of growth of nails of hands and Toes

Treatment and Advice:

Patient is given Composition B to apply locally twice a day and revisitafter 15 days

Patient 2^(nd) Visit:

Patient revisited 15 days after the first visit. Mother says that therehas been an improvement in growth. Patient is given the same CompositionB to apply twice a day in the same manner and revisit after one month.

Patient 3^(rd) visit:

Patient revisited one month after the previous visit. Mother says thathis nails of toes and fingers are growing and the size of nails has beenincreased. Patient is given the same Pharmacological Composition B toapply twice a day and revisit after one month.

Patient 4th Visit:

Patient revisited one month after the previous visit. His nails of handsand feet have become excellently increased in size. Mother says that nowshe is cutting his nails. Patient is given now Composition A to applytwice a day and revisit after one month.

Patient 5^(th) Visit:

Patient visited one month after the previous date and now the nails havebecome normally growing and increasing in size as per mother says. Onexamination of nails, nails had become normally grown. Patient is givenagain Composition A to apply locally twice a day and afterwards stop themedicine. Mother is also directed to revisit anytime if she feels thatafter the stoppage of medicine if growth is slow.

Patient 6^(th) Visit:

Patient visited 6 months after the previous date to say that his nailsare growing normally.

Patient: D

Age: 17

Gender: Female

Status: student of first year college

History of Complaint of Patient:

Patient states that her nails were in normal texture three years backwhile started to develop pin head depression of hand nails fingers. Withthe passage of time, these depressions developed in other nails also.Patient also gives the history of loss of hair on scalp at three spots.

On Examination of Patients:

On examination of nails of patients, there were pin head depressions infingers nails. On examination of her skin, there was loss of hair atthree spots. Patient did not have any history of a systemic disease.

Diagnosis:

Pitting on nails of hands due to the disease Alopecia areata

Treatment and Advice:

Patient is given Composition B to apply locally on affected nails twicea day and advised to re-visit after 20 days.

Patient 2^(nd) Visit:

Patient visited 20 days after the first visit and says that herdepressions of nail are appearing to be filled. On examination, of hernails depressions were reduced slightly. She is advised to revisit afterone month. She is given same Composition B to be applied locally twice aday in same manner as previously.

Patient 3^(rd) Visit:

Patient revisited one month after the previous date with markedimprovement. On examination of her nail, depressions were filling.Patient was given same Composition B and advised to revisit after onemonth and apply the medicine in same manner as previously.

Patient 4th Visit:

Patient visited one month after the last visit with excellent markedimprovement. Patient is given Composition A to apply in same mannerlocally twice a day and revisit after 15 days.

Patient 5^(th) Visit:

Patient revisited one month after the last visit with complete cure andthere were no pitting depressions in any of the nails. The treatment isnow stopped and advised to revisit if he feels any depression.

Patient 6^(th) Visit:

Patient visited 7 months after the last visit to complain that she isagain developing depression in two nails. She is again given theComposition B to apply only at night in all fingers nails and visitafter 6 months.

Patient: E

Age: 12

Gender: Female

Status: Student, Low socio-economic

History or Complaints of Patient:

Mother of child complains that nails of fingers and toes of her daughterare flat rather than convex and are adherent to nail beds since herchildhood and even there is no shining in her nails.

On Examination of Patients:

On examination of patient, her fingers and toe nails are flat andlusterless. By examining her whole body skin, there found no any sign ofskin disease. Patient mother does not give any history of current orpreviously of systemic disease except that she does not eat properly.She also complains of loss of appetite only. She also told that all herblood reports are normal which were done one month back. On examination,all nails of fingers and toes are flat and appear to adherent to nailbeds.

Diagnosis:

Flat nails of fingers and toes

Treatment and Advice:

Patient is given Composition B to apply locally twice a day and advisedto keep nails moisturized. Patient is directed to revisit after 20 days.

Patient 2^(nd) Visit:

Patient Revisited 20 days after the first visit. Her mother states thather nails are somewhat raised to nail beds. On examination of patientnails of hand and feet, appears to slightly rise. Patient is advised torevisit after one month.

Patient 3^(rd) Visit:

Patient revisited one month after the previous date. Mother says thatnails are improving and rising from the nail bed. On examination nailsare raised. Patient is given now again Composition B and advised torevisit after one month.

Patient 4th Visit:

Patient visited one month after the previous date. Her mother seem to bevery happy and states that all of her nails with the exception of twonails has become completely normal with raised to nail bed and haveacquired convexity and luster also. Now patient is given Composition Afor maintenance and advised to apply furthermore and revisit after onemonth.

Patient 5^(th) Visit:

Patient visited one month after the previous visit and says that her allnails have become normal now with convexity. On examination of patientnails, nail had become normal. Drug is stopped and advised to patientkeep her nails moisturized

Patient 6^(th) Visit:

-   -   Patient visited one year after the previous date with complete        cure and no reoccurrence of diseased.

Patient: F

Age: 40

Gender: Male

Status: Married, high socioeconomic, Engineer

History of Complaints of Patient:

Patient complains of deformed, roughness with strie nail for the lastone year. He says that his all nails were normal one year back while hefelt to develop roughness and strie in his index fingers of left nail inspite of getting different treatment, it was not going to be improved.He also says his rest of nails are normal.

On Examination of Patients:

On examination of patient, all of his nails of fingers and toes are ofnormal texture except roughness deformed and strie in left indexfingers. Patient does not give history of any skin disease. I examinedwhole of his skin, he has no skin lesions at any spot. Patient gives thehistory of Diabetes Mellitus for the last 3 years. Except DiabetesMellitus, he has no other systemic disease

Diagnosis:

Deformed Rough strie nail.

Treatment and Advice:

Patients is given Composition A and advised to apply locally twice a dayand visit after one month.

Patient 2^(nd) Visit:

Patient visited one month after the previous visit and said that he hasgot improvement; the nail growing from proximal is being corrected. Healso says that nail growth is also increased. He is cutting nail and thenail from growing place emerging normal. On examination, there is markedimprovement. Patient is given same Composition A and to apply in sameway and advised to revisit after one month.

Patient 3^(rd) Visit:

Patient visited one month after the previous visit with remarkableimprovement ad was very happy to say now his deformed nail of indexfingers has adapted normal texture. On examination his nail is growingfrom proximal is adapting normal texture declining of lining anddeformity. Composition A is given to apply locally and advised torevisit after one month.

Patient 4th Visit:

Patient revisited one month after the previous visit with highlyremarkably improvement. Nails proximally growing are attending normaltexture and declining lining stria and deformity. Patient is given sameComposition A and is advised to revisit after one month.

Patient: G

Age: 18

Gender: Female

Status: Unmarried, Student and Low Socio Economic.

History of Complaints of Patient:

Patient states that her nails were with normal growth and structurewhile she felt splitting of her fingers nails in her two fingers, whilethe small pieces may flake and the nails grow and flake at the tip ofthe fingers which gradually developed to split and flake in whole nailsfingers of hands.

On Examination of Patients:

On examination of the patient her whole fingers nails of hands weresplit into pieces and the growth of nails were restricted till tip ofthe fingers. On examination of the nails, nails are lusterless alsofurther examination of her skin there is no any indication of skindisease. She says that her hands remain mostly in water. She is notgiving any history of current or previous systemic or any skin diseases.

Diagnosis:

Splitting of nails into layers (onychoschizia) (Lamiler Dystrophy)

Treatment and Advice:

Patient is given Composition B and advised to apply locally twice a dayand revisit after 20 days. Patient is also advised to remain away fromwater and also keeps her nails moisturized.

Patient 2^(nd) Visit:

Patient visited 20 days after previous visit and says that her nails areimproving and now the splitting of nails is declined up to an extent.Patient is given same Pharmacological Composition B and advised to applyin same way as previously and revisit after one month.

Patient 3^(rd) Visit:

Patient visited one month after previous visit and is very happy as shesays that her splitting of nails has been subsided to a great extent andher nails are growing without splitting now beyond the tips of fingers.Now she is given Remedy A and advised to apply the medicine locally aspreviously and revisit after one month.

Patient 4th Visit:

Patient visited one month after the previous visit and says that now hernails are 90% improved and very less splitting than before. OnExamination of her nails there appears to be not any deformity. Patientis given the remedy A for maintenance and advised to revisit after onemonth.

Patient 5^(th) Visit:

Patient visited one month after the previous visit and says that now shehas got 100% cure and there is no splitting of nails. On examination hernails appears to be normal the treatment is stopped and advised thepatient if she feels any problem she can come back or normally revisitafter 6 month.

Patient: H

Age: 52

Gender: Male

Status: Married, Labor, Poor Socio Economic

History or Complaints of Patient:

Patient complains of his brittle nails since last 6 months in his allnails of hands and feet fingers. He also complains of lusterless and drynails. Patient says that his nails are brittle and breaking since 6months.

On Examination of Patients:

On examination of patient, his nails are brittle and lusterless. His allfingers and toes nails are affected. On examination of his skin there isno any lesion on skin. Even patient doesn't give any current or previoushistory of skin or any systemic diseases except that 8 months back hehad iron deficiency anemia for which he had got treatment and his anemiccondition was improved. Patient says that after correction of his evenanemic condition, he felt brittleness in his nails. Although his anemiccondition is corrected but nails are still brittle.

Diagnosis:

Brittle of nails due to iron deficiency anemia.

Treatment and Advice:

Patient is given Composition A and advised to apply locally twice a dayon affected nails. He is also advised to take diet properly and revisitafter one month.

Patient 2^(nd) Visit:

Patient visited one month after previous visit and says that now hisbrittle nails are improving. His nails are growing rapidly and nailsfrom proximal end are correcting. He is given same Composition A andadvised to revisit after one month.

Patient 3^(rd) Visit:

Patient visited one month after the previous visit and says that hisnails are improved more. He is given same Composition A to apply locallytwice a day and advised to revisit after one month.

Patient 4th Visit:

Patient visited one month after the previous date and says that he isnow improved up to an extent. Nails from proximal ends are adoptingnormally and are not brittle. Same Composition A is given and advised torevisit after one month.

Patient 5^(th) Visit:

Patient visited one month after the previous date and says that there ismarked improvement. Nails are returning back to its previous conditionbut still somewhat brittle. Same Composition A is given and advised torevisit after one month.

Patient 6^(th) Visit:

Patient revisited one month after the previous visit with near aboutcomplete cure. His remedy is stop and advised to keep his diet balancealso.

Patient: I

Age: 8 yrs.

Gender: Male

Status: Primary class student

History or Complaints of Patient:

Patient's mother complains of her child that his nails do not growbeyond the tip of fingers for the last one year. Mother states that hisnails of both hand's fingers were normal two years back. But after thatall fingers nails of both hands are not growing beyond the tip offingers. Mother also says that his toes fingers nails are growingnormally

On Examination of Patients:

On examination of all nails of toes and fingers, toes nails are normalbut fingers nails of both hands growth are restricted at the tip of thefingers. On examination of hands fingers nails appears to be bitten andafter asking the mother, She told that he was habitual of biting hisfingers nails after that nails restricted to grow but even after leavingthe biting of nails since last six months, even though nails are notgrowing normally. These restricted growths of nails are due tocontinuous biting of nails.

Diagnosis:

Diminished nail growth due to biting.

Treatment and Advice:

Patient is given Pharmacological Composition B to apply locally on allfingers nails twice a day and advised to keep the nails moisturized.Patient is advised to revisit after one month.

Patient 2^(nd) Visit:

Patient revisited one month after the previous visit. Mother states thathis nails are now growing. Same Composition B is given to apply in sameway as previously and revisit after one month.

Patient 3^(rd) Visit:

Patient revisited one month after previous visit. Mother is very happyto say that nails have started to grow normally. On examination of nailsof patients, nails are grown beyond the tip of the fingers. Patient isgiven now Composition A to apply in same manner as previously andadvised to revisit after one month.

Patient 4th Visit:

Patient visited one month after the previous visit. Mother is now veryhappy to say that now she is cutting the nails of his child andafterwards these nails are growing. Medicine is stopped and patient isadvised to moisturize his nails. Patient is also advised not to applyany medicine and revisit just for checking after 6 months.

Patient 5^(th) Visit:

Patient visited 6 months after the previous date for checkup. Mother isvery happy to say that now his nails are growing properly and normallyas these were before the disease.

Patient: J

Age: 72

Gender: Male

Status: Labor, Lowest socioeconomic, neglected

History or Complaints of Patient:

Patient complains of his deformed nail of right foot big toe nail. Hecomplains that he has come to you because of the deformed nail withraised from the nail bed and has acquired a strange shape. Patient alsocomplains of severe pain if it is touched to any solid object. He alsosays that he does not remember the time period but it is since longtime.

On Examination of Patients:

On examination of the toe's nails of the patient, it resembles likeRAM'S HORNS. Patient looks and attitude is appearing to be deficient indiet and is neglected person in the society. He is Labor and he saysthat no one does care of him in his family. He even does not cut hisnails since long time. He also says that he had to face trauma in hisnail so many times. His wife was died 8 years back and now days no onekeeps care of him. On overall examination, his all nails are not innormal texture, some nails have got style and some are brittle but hecame to me because his one toe nail is creating great problem for him ashe gets severe pain in it whenever it is touched to anything. He doesnot give the history of any local or systemic diseases but by appearanceappears to be deficient in diet. Patient gives the previous history ofsurgical removal of this nail but it reoccurred like same

Diagnosis:

Onychogryphosis (Ram's Horn Nails)

Treatment and Advice:

As there is no specific treatment of it but Some recommend avulsion ofthe nail plate with surgical destruction of the nail matrix with phenolor the carbon dioxide laser, if the blood supply is good. Even aftergetting treatment of surgical destruction, Patient again develop sameRam's Horn like nails within 3 months. I first adopted the Treatment tocut the ¾^(th) nail which was raised from the nail bed and laid the restof the nail remaining as it is. Then I gave the patient Composition B toapply locally from the remaining part of nail so that nail from the rootmight be growing normally and remain attached to nail beds. Patient isadvised to keep the nails moisturized and revisit after one month.

Patient 2^(nd) Visit:

Patient visited one month after the previous date to say that hisgrowing nails are appearing to be coming with the attachment of nailbed. On examination of his disease nail, Nail appear to be somewhatgrowing normally proximally and still are raised from the bed but verylittle. Patient is given the same Composition B and advised to apply thedrug in same way locally twice a day and revisit after one month.

Patient 3^(rd) Visit:

Patient visited one month after previous visit to say it is improving.On examination, Nail growth was increased and the nail was attached tonail bed somewhat but not like previously raised. Patient is again giventhe same Composition B and advised to revisit after 2 months and keepthe nails moisturized.

Patient 4th Visit:

Patient visited 2 months after the previous date to say that now thenail have been improved to an extent and it is not raised from the nailbed too much. He is also not feeling pain. Patient is given again thesame Composition B and advised to revisit after 3 months again.

Patient 5^(th) Visit:

Patient visited 3 months after the previous visit with the completeeruption of new growth of nail and is very happy but says that still itis raised from the nail bed but not like previous one like Ram's hornsand is improved and not feels pain even if it is touched with any of theobject. Patient is given the same Composition B and advised to revisitafter 3 month and advise to apply the drug locally in same way aspreviously.

Patient 6th Visit:

Patient visited 3 months after the previous visit with quite happy andsays that now his most of the proximal part of the nail have becomenormal and is attached to nail bed but distal part still raised from thenail bed but he does not feel any pain. On examination of hi affectednail, it has adopted normal texture up to a great extent and the half ofthe nail are attached with the nail bed and the distal part of nail isstill raised from the nail bed but not to that extent as it waspreviously. Nail from the proximal part is getting normal texture.Patient is cutting his nail as it grows beyond the tip of the finger.Patient is given now Composition A to apply locally as previously andmaintenance dose and advised to apply it regularly for two to fourmonths more and revisit afterwards.

Patient 7th Visit:

After the last visit, Patient did not come back.

The active compositions of this invention are rapidly and highly solublein water and thus are rapidly absorbed onto and into nails, wet skinrather than on dry skin. It is thus preferred that the compositions betopically applied to skin/nail surface that has been moistened withwater.

As the active composition when applied to the skin can create dryness,it is thus desirable to have a formulated pharmacological compositionthat is greasy. However, when treating acne this drying ability isbeneficial and thus the final composition should be non-greasy or haveless of a greasy feel or property.

The active compositions are rapidly absorbed per cutaneously and enterin to the bloodstream. Therefore it is advisable that when the drug isapplied to a large area, for example in the treatment of psoriasis, thepatient should be kept under observation by the physician.

The active composition may also lower blood pressure as it is absorbedthrough the skin. It is thus advisable not to treat patients less than 5years old or applied under strict supervision at a low concentration ofactive composition and/or treating small areas.

If given orally it may cause nausea, vomiting and diarrhea. It thereforeshould be taken a half hour before food or one hour after food.

Treatment of Hair Loss, Hair Fall and Alopecia

An aspect of this invention is directed to compositions, systems andmethods for treating, ameliorating, and/or preventing “hair fall”, i.e.,hair loss, and/or stimulating hair growth in a person, patient ormammal. This invention relates to a method of minimizing or preventingundesirable hair fall from all over the skin or localized areas of theskin, including but not limited to the scalp, face, eyebrows, beardarea, axillae, e.g., armpits, genital area and localized patches of baldhair (Alopecia) due to systemic or local causes and/or stimulating hairgrowth in such areas. The method of treatment for such hair fallcomprises topically applying or administering to the area requiring suchtreatment a specific composition comprising, a mixture of sodium oxalateand oxalic acid in a specific stoichiometric ratio (percentage, byweight), and which may include a percentage of benzoic acid, salicylicacid and/or clobetasol, e.g., clobetasol propionate (a topical steroid)in a pharmacological composition comprising a pharmaceutical carrier.

The treatment of this invention is safe, effective and reduces and/orprevents hair loss and can stimulate hair growth in the treated area.Although not bound by such theory, it appears that repeated applicationactivates a non-specific suppressor mechanism to suppress effector cellsthat are responsible for hair loss.

There are many hair loss conditions.

1) Alopecia Areata: Among the many factors which appear to be implicatedin at least a proportion of such cases are the patient's geneticconstitution, the atopic state, non-specific immune and organ specificautoimmune reactions and emotional stress. Characteristics are aninitial lesion of a circumscribed total bald smooth patch

2) Trichotillomania: A compulsive habit which induces an individual topluck his or her hair repeatedly. The result an ill-defined patch onwhich the hairs are twisted and broken at various distances from theclinically normal scalp. Much more unusual is the habit of excessivelyplucking the eyebrows and beard. The patient may pluck hair also or onlyfrom other region of the body such as pubis. These conditions commonlyoccur in neglected children and also in mentally retarded persons.

3) Brush Roller Alopecia: If brushing is applied frequently and with toomuch vigor this may cause irregular patches that appear like alopecia.

4) Hot comb alopecia: Typically women, usually black women, who use hotcombs to straighten their hair may develop this type alopecia.

5) Massage Alopecia: The overenthusiastic application of medication tothe scalp with massage may cause such baldness.

6) Alopecia secondary to hair weaving: Patchy traction alopecia has beenreported to result from the cosmetic procedure of weaving.

The invention described herein provides an improved treatment method forhair loss that is effective, low cost, with minimal or no side effectsusing an easy to manufacture pharmacological composition for thetreatment of hair fall and loss of hair and stimulating hair growth. Thecomposition is applied to the areas of the skin, e.g., scalp, beard areaand or other areas of the skin that have hair loss. The treatment canalso be used for ameliorating, preventing and/or treating hair fall andhair loss diseases (Alopecia) and stimulating hair growth.

The method of this invention for treating hair fall and hair loss and/orstimulating hair growth comprises topically administering to a mammal apharmacological composition, comprising a sodium oxalate and oxalic acidmixture with specific ratio by weight and percentage. A preferredcomposition for treating above mentioned conditions comprises acomposition that includes a sodium oxalate and oxalic acid mixture witha specific stoichiometric ratio at 2.5% by weight in the topicalcomposition that may have benzoic acid, salicylic acid and clobetasol.

Example

Preparation of Active Composition of Sodium Oxalate and Oxalic Acid.

An equal amount by weight of a pharmaceutical grade sodium bicarbonateand oxalic acid are placed in a plastic container in a sterile openspace at room temperature, i.e., 25° Celsius. The composition is mixeduntil a uniform mass is formed. A sufficient amount of purified sterilewater is poured slowly into the container to allow the reaction ofsodium bicarbonate and oxalic acid. The mixture is left for 24 hours topermit the water and carbon dioxide to evaporate and the mixture to dry.The mixture is then stirred again to permit the carbon dioxide and watervapors to further escape. Finally a white crystalline and odorlesspowder is obtained. The final product consists of 78.44% sodium oxalateand 21.56% Oxalic acid. The measured pH of the final product is 6. Thissolid product is now crushed and ground to a fine powder to produce theactive composition, suitable for incorporation into a pharmaceuticalcarrier or vehicle.

Preparation of Pharmacological CompositionsA. Preparation of Oil and Water Based Pharmaceutical Carrier or Vehicle(“Vehicle A”) (1000 Grams on Small Scale):

-   -   1. Vessel A: Provide 750 grams of purified and sterile water in        a suitable container, e.g., stainless steel vessel, and heat to        about 70° Celsius.    -   2. Vessel B: Provide 250 grams of a pharmaceutical grade        emulsifying wax and melt it by heating to 70° Celsius in a water        bath.    -   3. Pour the heated water on Vessel A into Vessel B containing        the emulsifying wax slowly and gradually, continue to stir to        mix properly until wax and water become uniform and thickened,        and temperature comes down to 35° Celsius, then let stand to        cool. This water and oil base contains 25% emulsifying wax and        75% water by weight.        B. Addition of Active Composition, Benzoic Acid, Salicylic Acid        and Clobetasole to Oil and Water Based Vehicle to Produce the        Pharmacological Composition Used:

1. Preparation of the Pharmacological Composition for the Treatment ofAlopecia (“Pharmacological Composition A”)

A preferred pharmacological composition used for the treatment ofalopecia consists of:

2.5% by weight of the active composition,

1.5% by weight of benzoic acid,

0.75% by weight of Salicylic Acid,

0.025% by weight of clobetasol

90.725% by weight of the oil and water based vehicle.

A preservative may be added as needed that maintains about the sameratios of ingredients and does not react with any ingredient of vehiclenor with any active composition.

2. Preparation of the Pharmacological Composition for the Treatment ofHair Fall (“Pharmacological Composition B”)

A preferred pharmacological composition used for the treatment of hairfall consists of:

2.5% by weight of the active composition,

6.0% by weight of benzoic acid,

3.0% by weight of Salicylic Acid,

0.005% by weight of clobetasol

88.495% by weight of the oil and water based vehicle.

A preservative may be added as needed that maintains about the sameratios of ingredients and does not react with any ingredient of vehicleor with any active composition.

Method of Treatment

The pharmacological composition may be applied locally to the diseasedor afflicted patients on the affected skin area of the scalp, face andor other skin areas that need to be treated. A therapeutically effectiveamount of pharmacological composition is applied to such skin area thatwill ameliorate, prevent and/or minimize hair fall and loss of hairand/or stimulate hair growth. Contact with the eyes with thepharmacological composition should be avoided.

Clinical Trials with Pharmacological Composition A

Patient: A

Age: 07

Gender: Male

Status: low socio-economic

History of Complaints of Patient:

Parents of child complains that his scalp was normal with erupted hairsone year back then all of a sudden gradually his hair were being lostand within one year it became a patch of hair loss within that period healso developed hair loss on back of the head. Patient got treatment fromdifferent doctors but there was no remarkable hair growth particularlyon back of head.

Examination of Patient:

On examination of patient, there was a small patch of loss of hair onthe center of scalp and also on occipital area there was big patch ofAlopecia known ophiasis. There is poor prognosis in this condition. Onexamination of nails, there was pitting in 3 nails of fingers. Aftertaking history from parent, Atopic condition lies in his family and onexamination of patient after taking history case was diagnosed as atopicdermatitis. Laboratory investigation: IgE was high and complete bloodpicture showed eosinophilia. There was history of Bronchial asthma inhis family.

Diagnosis:

Alopecia Areata

Treatment and Advice:

Patient is given Pharmacological Composition A and advised to applylocally to the hair loss area, twice a day and advised to revisit after15 days

Patient 2^(nd) Visit:

Patient revisited 15 days after first visit to say that his hair hasbeen regrown to a vast extent on scalp and on back of head. Onexamination of patient there was remarkable growth of hair on scalppatch and on occipital area patch. Patient is again given the samePharmacological Composition A to apply in same manner and advised torevisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the second visit, parents said that morehairs has been grown. On examination of patient remarkable growth ofhair were observed on both patches. Patient was given the samePharmacological Composition A to apply locally and also advised torevisit after 15 days.

Patient 4th Visit:

Patient came 15 days after the 3^(rd) visit with complete eruption ofhair on both hair loss patches. Treatment was stopped. Patient wasadvised to revisit after 3 months.

Patient 5^(th) Visit: Patient revisited after 3 months of the last visitwith same erupted hair.

Patient: B

Age: 21

Gender: Female

Status: Unmarried

History of Complaints of Patient:

Patient states that her elder sister suddenly noted a loss of hair onpatient's scalp with round big patch. Patient did not see and know thelength of time since she had developed this patch without hair.

Examination of Patient:

The patent had no history of previous diseases. On examination ofpatient there was a big patch of circumscribed bald area without hair.Additional investigations were performed, including CBC, Thyroidprofile, RA factors. All investigations were normal.

Diagnosis:

Idiopathic Alopecia Areata

Treatment and Advice:

Patient is given Pharmacological Composition A and advised to applylocally twice a day. She is also advised to revisit after 15 days

Patient 2^(nd) Visit:

Patient visited 15 days after the first visit and said that more than40% hair had erupted. On examination, there were some hair growth andmore than 40% hair had grown on bald patch. Patient was given samePharmacological Composition A to apply in same manner twice a day andadvised to revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit with satisfaction. OnExamination, it was found that more hair had grown. Patient was giventhe same Pharmacological Composition A & advised to revisit after 15days.

Patient 4th Visit:

Patient visited 15 days after the previous visit. On examination ofpatient her bald area were fully covered with hair. Treatment wasstopped. Patient was advised to revisit after 3 months.

Patient 5^(th) Visit:

Patient revisited 3 months after previous visit to say that she isfeeling slight baldness on scalp on same area. Patient was givenPharmacological Composition A to apply locally twice a day and advisedif she feels further hair loss on bald area, she may revisit.

Patient: C

Age: 32

Gender: Male

Status: Married

History of Complaint of Patient:

Patient complains of loss of hair over the past 3 months. Patient saysthat he first developed a small bald patch and gradually developed twomore bald patches.

Examination of Patient:

On examination of patient, there were 3 small bald patches without hair.Patient does not have any history of systemic or local skin disease buthe appears stressed. Additional investigations indicated there were nodiseases, i.e., all was normal.

Diagnosis:

Alopecia Areata due to emotional stress.

Treatment and Advice:

Patient is given Pharmacological Composition A to apply locally twice aday and revisit after 15 days

Patient 2^(nd) Visit:

Patient revisited 15 days after the first visit to say that there is nohair growth. On examination of patient, there seems no appearance ofhair growth. The same Pharmacological Composition A was given to patientto apply twice a day and advised to revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit to say that hiscondition is same as it was. On examination of patient No hair growthobserved. Same Pharmacological Composition A was given to patient toapply twice a day and advised to revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit to say that now somehair are growing. On examination of patient some hair were erupted atdistance. Patient was given again the same Pharmacological Composition Ato apply in same manner.

Patient 5^(th) Visit:

Patient revisited 15 days after previous visit. On examination there wasmore hair growth. Patient was advised to revisit after 15 days. Patientwas given same Pharmacological Composition A to apply in same manner andrevisit after 15 days.

Patient 6^(th) Visit:

Patient came after 15 days of previous visit. On examination much morehair erupted and now the bald area appears to be somewhat covered.Patient again given same Pharmacological Composition A and advised torevisit after 1 month.

Patient 7^(th) Visit:

Patient revisited one month after previous visit to say there is slightmore hair growth but not remarkable. On examination few more hairs areerupted. Patient given same Pharmacological Composition A to applylocally in same manner till the whole of the bald patches are coveredwith hair.

Patient: D

Age: 16

Gender: Female

Status: Unmarried

History of Complaints of Patient:

Patient complains of hair loss on eyebrows for the last 3 months.Patient said that she was alright 3 months before and then startedshedding of hair gradually and within 3 months she lost half of eye browhairs on both eyes. Patient did not have any history of systemic orlocal skin disease. Patient provided the genetic history of her fatherwho also had developed hair loss.

Examination of Patient:

On examination of patient she had developed patches of hair loss on botheyebrows. Investigation did not reveal any hidden diseases.

Diagnosis:

Genetically determined Alopecia Areata.

Treatment and Advice:

Patient is given Pharmacological Composition A to apply locally twice aday and advised to revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit to say that some hairhad been grown. On examination some hair had grown and patient wassatisfied. Patient was given the same Pharmacological Composition A toapply locally in the same manner and advised to revisit after 15 days.

Patient 3^(rd) Visit:

Patient visited 15 days after previous visit with satisfaction. Onexamination of patient 75% hair had grown back and was covering theareas which had lost hair. The patient was give same PharmacologicalComposition A to apply in the same manner and advised to revisit after15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit with fullsatisfaction. On examination of patients eyebrows the hair loss wascompletely restored and treatment was stopped. The patient was advisedto revisit if she experienced hair loss.

Patient: E

Age: 42

Gender: male

Status: Married

History of Complaints of Patient:

Patient complained of hair loss on head and also on front of lower partof right leg. The patient complained that hair loss started about 4months earlier. His head hair started shedding and gradually he acquireda big bald patch of hair on his head. Within the same period of time hisfront of right lower leg started gradually shedding hair. The patienthad a big bald patch on his front of right lower leg.

Examination of Patient:

On examination of the skin of the patient, there were 2 big bald patcheson his head and one on the front of his right lower leg. Investigationof patient did not reveal any diseases. Overall examination of thepatient revealed him to be under emotional stress.

Diagnosis:

Stress induced Alopecia Areata

Treatment and Advice:

Patient was advised to try and minimize his stress. Patient was givenPharmacological Composition A, to apply twice a day locally and revisitafter 15 days.

Patient 2^(nd) Visit:

Patient visited 15 days after first visit but there was only limitedhair growth. Patient was given the same Pharmacological Composition A toapply twice a day in same manner and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit with slightimprovement and hair erupted more rapidly on effected area. Patient isgiven same Pharmacological Composition A to apply on both affected areain same manner and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after previous visit with good prognosis andmore hairs had erupted. Patient given the same PharmacologicalComposition A to apply in the same manner and revisit after 15 days

Patient 6^(th) Visit:

Patient revisited 15 days after the previous visit with moreimprovement. More hairs had erupted on the patient. He was given thesame Pharmacological Composition A to apply in the same manner andrevisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after previous visit with good hair growth.Additional hairs had erupted. The patient was given the samePharmacological Composition A to apply in same manner and advised torevisit after 15 days.

Patient 7^(th) Visit:

Patient revisited 15 days after the previous visit. On examination ofthe patient full growth of hair had erupted and patient was satisfied.All treatment stopped.

Patient: F

Age: 40

Gender: Female

Status: married

History of Complaints of Patient:

Patient complained of loss of hair on front right side of scalp. Patientdoes not remember how long she had developed this area without hair. Herhusband said that it had developed gradually over the past year.

Examination of Patient:

On examination of patient she had a big bald patch without hair growthon her head. In some places rudimentary hair was visible. After takingher detailed history, her husband said that their youngest son age 18years had died in accident, Since that time she had stress and tensionand was deliberately pulling her hair out.

Diagnosis:

Traumatic Alopecia (Trichotillomania)

Treatment and Advice:

Patient was advised not to pull her hair. Her husband was directed towatch her. Patient was given Pharmacological Composition A to applylocally twice a day and revisit after 15 days.

Patient 2^(nd) Visit:

Patient visited 15 days after previous visit with eruption of hair.Patient given same Pharmacological Composition A to apply locally twicea day in the same manner and revisit after 15 days. Patient's husbandwas again directed to watch her and try to prevent pulling hair out.

Patient 3^(rd) Visit:

Patient revisited after 15 days of previous visit with more hair growthand the bald area was covered with hair growth. The patient's husbandwas again directed to watch her and try to prevent pulling hair out.Patient was given the same Pharmacological Composition A to apply twicea day and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after previous visit with almost all hairgrown back. Patient was given Pharmacological Composition A to apply inthe same manner. Patient was advised to revisit after one month.

Patient 5^(th) Visit:

Patient revisited one month after previous visit. On examination ofpatient all her bald patch areas were covered with hair. Treatment wasstopped and patient's husband was directed to keep care of her as sheshould not pull her hair and better to consult psychiatrist for hermental condition as if she again pulls hair, she will again develop baldarea.

Patient: G

Age: 12

Gender: Male student

Status: student

History of Complaints of Patient:

Patients parents brought a 12 year child with loss of hair on side offront scalp region that occurred over the past 1 year

Examination of Patient:

On examination of the patient there was loss of hair and a visible baldpatch on frontoparietal area. After taking history from parents theysaid that he complained of nausea and vomiting. After thoroughly takinghistory of patient, parents said that he pulls out hair and eats thehair. They were also asked about his behavior and attitude. The parentssaid that he is slightly neglected as they give more attention and loveto eldest son. The parents were told not to neglect him and divert hisattention to keep him busy so that he would not pull out his hair andeat it.

Diagnosis:

Traumatic Alopecia (Trichophagy)

Treatment and Advice:

Patient was given Pharmacological Composition A to apply twice a day andadvised the parents to give more attention to him and keep care of himnot to pull and eat the hair. Patient should be given biscuits andtoffee and other items he liked. Patient was advised to revisit after 15days.

Patient 2^(nd) Visit:

Patient revisited 15 days after previous visit and examination at adistance indicated that some of the hair had erupted. Patient was givensame Pharmacological Composition A to apply twice a day and the parentswere directed to keep care and watch him.

Patient 3^(rd) Visit:

Patient revisited 15 days after previous visit with excellentimprovement. Hairs had erupted nearer to each other. The patient wasgiven the same Pharmacological Composition A and advised to apply in thesame manner and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after previous visit with remarkableimprovement. His bald patch was covered with hair with remarkable lengthof hair. Patient was given the same Pharmacological Composition A toapply in same manner and continue to apply furthermore for one month.Parents were directed to keep care of their child not to pull or eat thehair. Treatment is stopped.

Patient: H

Age: 30 years

Gender: Female

Status: Married

History of Complaints of Patient:

Patient complains of hair loss on the centre of scalp for last one year.Patient said that she began to shed her hair gradually over the pastyear. She tried different treatments but no beneficial results wereobtained.

Examination of Patient:

On examination of patient, the center of the scalp acquired welldemarcated big bald patch without hair with a dry rough scalp. Aftertaking family history it revealed that her elder sister also developedthe same bald patch. She also stated that her mother also had the samehair loss at about the same age.

Diagnosis:

After taking full history, patient diagnosed as Androgenic Alopecica

Treatment and Advice:

Patient is given Pharmacological Composition A to apply locally twice aday and revisit after 15 days.

Patient 2^(nd) Visit:

Patient visited 15 days after previous visit but there was noimprovement at all. Patient is given same Pharmacological Composition Ato apply twice a day and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit but there was stillno improvement and no eruption of hair. Patient given PharmacologicalComposition A and advised to revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after previous visit. On examination thereappears to be 2 to 3 hairs erupting. Patient is given PharmacologicalComposition A to apply locally twice a day and revisit after 1 month.

Patient 5^(th) Visit:

Patient revisited 1 month after previous visit and examination ofpatient, there were only several hairs that had erupted. On examination1 or 2 rudimentary hairs had erupted. Patient advised to revisit 1 monthafter previous visit.

In Androgenic Alopecia there was no rapid good result of treatment onlyone or two rudimentary hair are erupting at distances after two to threemonths. Patient was given same Pharmacological Composition A to apply insame manner and same way for prolonged period and time to time visithere when the Pharmacological Composition A is finished.

Placebo Control Study

We selected our 3 diseased patients of Alopecia having different knownpathology or idiopathic. We applied the simple vehicle based (Water andOil based with emulsifying wax) and observed the effects of givenapplied vehicle to apply locally.

TABLE A: Oil and purified water based vehicle (without incorporatedpharmacological mixture)

Placebo Control Patient: A

Age: 25 YEARS

Gender: Female

Status: Married

History or Complaints of Patient:

Patient complained of hair loss of frontal area of skull for the pastyear.

Examination of Patient:

On examination of patient there was found a big patch of bald area.Patient said that for cosmetic purpose she frequently and vigorouslyused a roller. Her loss of hair was due to such use.

Diagnosis:

Traumatic Alopecia

Treatment and Advice:

Patient was given Vehicle A and advised to apply a cream twice a day.And revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit. There was noimprovement at all, i.e., no hair growth. Patient was given the sameVehicle A to apply twice a day and advised to revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after previous visit. Upon examination ofpatient the bald patch remained the same. No hair growth at all. Patientis advised to revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit without having anyhair eruption. On examination lesion was same as 2 months back. Noapplication of vehicle A treatment stopped.

Placebo Control Patient: B

Age: 50

Gender: Male

Status: Married

History of Complaints of Patient:

Patient complain of Hair loss for the last 2 years which were graduallyfalling and acquired a big patch of Bald hair on center of scalp.

Examination of Patient:

On examination, Patient did not give any history of any systemic orlocal skin disease.

Diagnosis:

Androgenic Alopecia

Treatment and Advice:

Patient is given Vehicle A to apply twice a day and revisit after 15days

Patient 2^(nd) Visit:

Patient revisited 15 days after the first visit. On examination ofpatient, there was no hair growth. Patient was given same Vehicle A toapply twice a day and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit. The conditionremained the same. Upon Examination of patient there was no hair growth.Patient was given same Vehicle A to apply twice a day and revisit after15 days.

Patient 4th Visit:

Patient visited 15 days after the previous visit. There was noimprovement.

Upon examination of patient his bald patch had not changed. There was nohair eruption at all. Treatment stopped.

Placebo Control Patient: C

Age: 8 years

Gender: male

Status: student

History of Complaints of Patient:

Patient's parents complained of bald spots on scalp at 2 areas, one onfront of scalp, other on side of scalp that appeared over the last 6months.

Examination of Patient:

The two small bald patches without hair were observed. Parents said thathe had bronchial asthma.

Diagnosis:

Alopecia Areata due to atopic dermatitis

Treatment and Advice:

Patient was given Vehicle A and instructed to apply twice a day andrevisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after previous visit without any improvement.Upon examination of patient, the lesions remained same.

Patient 3^(rd) Visit:

Patient revisited 15 days after previous date but on examination noimprovement. Lesion somewhat extended.

Patient 4th Visit:

Patient revisited 15 days after previous date without having anyimprovement, the lesion extended. Treatment is stopped as there is noimprovement at all.

Clinical Trials with Pharmacological Composition B

Patient: A

Age: 50

Gender: female

Status: Married

History of Complaints of Patient:

Patient complains of hair fall over the last 2 months. Patient also saysthat her hair falls out with slight combing or using soap. Patient saysthat when she awakes in morning, hair appears on her pillow

Examination of Patient:

On examination of patient she has very low density of hair by mytouching hands on her hairs begins to fall. Patient is known case ofbreast cancer and she is on chemotherapy for the last two months.

Diagnosis:

Hair fall due to chemotherapy

Treatment and Advice:

Patient given Pharmacological Composition B to apply to the scalplocally at night. Before applying the Pharmacological Composition B sheis directed to moisturize her scalp and hair with cooking oil and wateror otherwise with any hair conditioner. Patient is advised to revisitafter 15 days

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit with slightimprovement and hair erupted more rapidly on effected area. Patient wasprovided with Pharmacological Composition B to apply on both affectedarea in same manner and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after previous visit which good prognosis andmore hairs were erupted. Patient was given Pharmacological Composition Bto apply in same manner and advised to revisit after 15 days

Patient 4th Visit:

Patient revisited 15 days after the previous visit with moreimprovement. Further hairs were erupted patient was givenPharmacological Composition B to apply in same manner and revisit after15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after previous visit with good hair growth.Additional hairs had erupted. Patient was given PharmacologicalComposition B to apply in same manner and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after previous visit. On examination ofpatient had full growth of hair and the patient was satisfied with thehair growth. All treatment stopped.

Patient: B

Age: 20

Gender: Male

Status: College student.

History of Complaints of Patient:

Patient complains of his hair fall from all over scalp over the last 3month. Patient says that during combing, hair washing and even itself bytouching hair and giving slight pulling his hair falls out.

Examination of Patient:

On examination of patient he has little density of hair on his scalp.After thorough checkup, e.g., blood CBC, Thyroid profile, RA Factor,etc. he appeared to be normal. He did not have any systemic or localdisease.

Diagnosis:

Idiopathic Hair fall.

Treatment and Advice:

Pharmacological Composition B was given to patient to apply at nightlocally. Before applying the composition the patient was directed tomoisturize his scalp and hair either by cooking oil and water or anyhair conditioner. He was also advised to wash his hair with suitableshampoo the next day. He was advised to revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after previous visit. Patient said that he hadimprovement and his hair falling had declined to some extent. Patientwas told to repeat the same treatment with Pharmacological Composition Band revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after previous visit and states that he hashad greater improvement, i.e., less falling hair. Patient was told torepeat the same treatment with Pharmacological Composition B and revisitafter 15 days.

Patient 4th Visit:

Patient revisited 15 days after previous visit and said he had 50%improvement in falling of hair, i.e., less hair fall. Patient was toldto repeat the same treatment with Pharmacological Composition B andrevisit after 15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after previous visit and said that he had a75% improvement in falling of hair. Patient was told to repeat the sametreatment with Pharmacological Composition B and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after previous visit to say that he hasobtained a remarkable improvement and minimal hair fall. Treatment wasstopped.

Patient: C

Age: 35 years

Gender: Female

Status: Married

History of Complaints of Patient:

Patient complained of her hair fall for the last 2 years. Patient saidthat her hair fall was too great. When combing, washing hair and evenwhen she awakes in the morning she sees the hair on the pillow.

Examination of Patient:

Upon examination of patient, her scalp hair was of low density and wasvisible upon observation. Examination of patient, e.g., blood CBC, RAfactor and thyroid profile, patient had Hypothyroidism and was usingthyroxine medicine

Diagnosis:

Hair fall due to Hypothyroidism.

Treatment and Advice:

Patient was given Pharmacological Composition B to apply on scalp atnight. Patient was directed to apply cooking oil and water or any hairconditioner before applying Pharmacological Composition B and is advisedto revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit and observationsindicated a slight improvement, although there was still hair fall.Patient was told to repeat the same treatment with PharmacologicalComposition B and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit and improvement wasobserved. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit to say that she wasgetting remarkable improvement. Patient was told to repeat the sametreatment with Pharmacological Composition B and revisit after 15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after the previous visit and patient say thatshe had 50% relief in hair falling. Patient was told to repeat the sametreatment with Pharmacological Composition B and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after the previous visit and patient statethat she had excellent improvement, but hair was still falling. Patientwas told to repeat the same treatment with Pharmacological Composition Band revisit after 15 days.

Patient 7^(th) Visit:

Patient revisited 15 days after the previous visit and patient statedthat falling of hair has almost stopped, but a few hairs are stillfalling during combing and washing. Patient was told to repeat the sametreatment with Pharmacological Composition B in same manner for 1 monthmore and after that stop the therapy.

Patient: D

Age: 10 years

Gender: male

Status: Student, low socioeconomic

History of Complaints of Patient:

Patient's mother complained of fall of hair from scalp of her child. Shestated that he gets hair fall after combing, after taking a bath andeven by touching and slight pressure on hair. Patient's mothercomplained of fall of hair for the last 8 months.

Examination of Patient:

On examination of patient, patient looks anemic. His CBC report showgrossly anemic.

Diagnosis:

Hair fall due to Anemia

Treatment and Advice:

Patient given Pharmacological Composition B to apply at night only andwash out next day. Patient is directed to apply oil and water or anyhair conditioner on scalp and hair before applying PharmacologicalComposition B. Patient's mother is also directed to feed him goodbalanced diet so that his anemic condition is corrected with thetreatment and the child gets rapid benefit of treatment. Patient isadvised to revisit after 15 days.

Patient 2^(nd) Visit.

Patient revisited 15 days after the previous visit with slightimprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit. There was animprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit. Patient had greaterimprovement in hair fall. Patient was told to repeat the same treatmentwith Pharmacological Composition B and revisit after 15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after the previous visit. Patient hair fallhad improved remarkably. On examination of patient, his anemic conditionalso improved. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after the previous visit. Patient hair fallhad vastly improved and only few hairs are falling during combing andwashing. The hair shedding had stopped. Patient was told to repeat thesame treatment with Pharmacological Composition B and revisit after 15days.

Patient 7^(th) Visit:

Patient revisited 15 days after the previous visit with remarkableimprovement in hair fall. Treatment was stopped and the patient wasdirected to watch his Anemic condition and was provided with supplementdiet instructions.

Patient: E

Age: 42 years

Gender: Female

Status: Married

History of Complaints of Patient:

Patient complained of her hair fall for the last 2 years. Patient statedthat there was hair fall after combing, after washing and even with onlyslight traction of hair for binding with clip.

Examination of Patient:

On examination of patient she had low density of hairs. Most of the areaof the scalp was devoid of hair. The patient's hairs appeared to berough. After taking a complete history of the patient, she was notsuffering from any systemic or local disease of the skin. Theinvestigation included CBC, Thyroid profile, and RA factor. All wasnormal. She indicated that the relationship with her husband was notgood. They quarreled and he was not a compromising person. She said thatthe tension was constant, i.e., “around the clock”.

Diagnosis:

Hair fall due to tension

Treatment and Advice:

She is given Pharmacological Composition B to apply only at night.Before applying Pharmacological Composition B she is instructed to,moisturize the scalp and hair with either Oil and water or with any hairconditioner and wash her hair next day. The patient is also advised tocompromise with her husband and adopt a polite attitude to attract himso that she may get rid of tension. Patient was requested to revisitafter 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit with slightimprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit with furtherimprovement in her hair fall as she stated. Patient was told to repeatthe same treatment with Pharmacological Composition B and revisit after15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit patient and statedthat she had excellent improvement in her hair fall. Patient was told torepeat the same treatment with Pharmacological Composition B and revisitafter 15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after the previous visit. Now patient statesthat she has got remarkable improvement in hair fall. Patient wasrepeated same REMEDY and advised to use it in same manner as it was toldpreviously and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after the previous visit. She had fullsatisfaction and there was a remarkable improvement in her hair fall,She had only a few hairs fall during her application of pressure fromcombing and washing. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 7^(th) Visit:

the patient revisited 15 days after the previous visit to state thatthere was excellent improvement and only few hair sometimes fall.Treatment stopped but patient is again advised and directed tocompromise with her husband and keep your marital life happy because ifyou again remain in stress and tension, the hair may again begin tofall.

Patient: F

Age: 16 years

Gender: Female

Status: college student

History of Complaints of Patient:

Patient complained of hair fall for the last 3 years. Patient statedthat any slight force applied on hair, e.g., combing or washing hair,the hair begins to fall. She also complained that even without applyingany pressure to the hair, it would fall out. When she awoke in themorning, her pillow had fallen hair.

Examination of Patient:

Her fingers appeared to be swollen. She also complained of Joints painfor the last 3 years according to statement of patient. She hasRheumatoid arthritis and is on anti-Rheumatoid arthritis medicine.Further examination confirmed that she is suffering from RA.

Diagnosis:

Hair fall due to Rheumatoid Arthritis

Treatment and Advice:

Patient given Pharmacological Composition B to apply at night andadvised to wash her hair the next day. Patient was directed tomoisturize her hair either with cooking oil and water or any haircondition. Patient was advised to revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit with slightimprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit with slight moreimprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit with good improvementand the fall of hair has been stopped to a great extent. Patient wastold to repeat the same treatment with Pharmacological Composition B andrevisit after 15 days.

Patient 5^(th) Visit:

Patient revisited 15 days after the previous visit with moreimprovement. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 6^(th) Visit:

Patient revisited 15 days after the previous visit with excellentimprovement and said that hairs are still falling but not too much andvery few are falling. Patient was told to repeat the same treatment withPharmacological Composition B and revisit after 15 days.

Patient 7^(th) Visit:

Patient revisited 15 days after the previous visit to state that she hasremarkable improvement with the stoppage of hair fall and only few hairsas normally falls are falling. Treatment is stopped and patient isadvised to continue to take her medicine for Rheumatoid Arthritis.

Placebo Control Study

We selected 3 patients having hair fall but different known pathology oridiopathic. We applied Vehicle A consisting of an oil and water basedmentioned below without any active ingredients of our pharmacologicalcomposition. The patients were not told that this was a placebo VehicleA, but told them it was a treatment composition for their hair fall.

Patient: A

Age: 35 yrs

Gender: Male

Status: Married

History of Complaints of Patient:

Patient complained of hair fall from his scalp for the last 2 years. Hesays that his hair fall occurred after combing his hair and washing andeven without any pressure on his hair. This occurred over the past 2years. Patient says that he received treatment from different doctorsbut he could not obtain relief

Examination of Patient:

Upon examination of patient and after taking his history, patient washealthy and not suffering from any systemic or local illness.

Diagnosis:

Idiopathic Hair fall.

Treatment and Advice:

Patient is given Vehicle A to apply at night only. Before applying thevehicle, he is advised to wash his hair the next day and advised torevisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit. Patient stated thatthere is no improvement at all. Hairs were falling at the same rate aspreviously observed. Patient was told to repeat the same treatment withVehicle A and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit disheartened andindicating the treatment is not effective. He asked to change thetreatment. Patient was told to repeat the same treatment with Vehicle Aand revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit. He was veryirritated to say I am not getting improvement at all. Thank you for yourtreatment I will change my doctor.

Patient: B

Age: 18 years

Gender: Female

Status: student, unmarried

History of Complaints of Patient:

Patient complained of hair fall for the last 2 years. She said that asshe combed her hair, washed her hair or gave a slight traction to hair,her hair fell out.

Examination of Patient:

Upon examination of the patient and taking history of patient she hadJuvenile Rheumatoid Arthritis

Diagnosis:

Juvenile Rheumatoid Arthritis

Treatment and Advice:

Patient is given Vehicle A to apply at night only. Before applyingVehicle A she should moisturize her hair with either cooking oil andwater or with hair conditioner and wash her hair next day with anysuitable shampoo. Patient is advised to revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit to say that thereappears no improvement at all. Patient was told to repeat the sametreatment with Vehicle A and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit to say that she isnot satisfied with the treatment. Patient did not want to continuetreatment. Patient was told to repeat the same treatment with Vehicle Aand revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit with very irritablemood to say that she was not getting improvement at all and withdrewfrom treatment.

Patient: C

Age: 50 years

Gender: male

Status: married

History of Complaints of Patient:

Patient complained of hair loss for a long time. He complained that hishair falls by itself and there was increased hair fall on combing andwashing.

Examination of Patient:

After taking his history, patient is a diabetic and is on anti-diabeticmedicine.

Diagnosis:

Hair fall probably due to his medicines and diabetes.

Treatment and Advice:

Patient was given Vehicle A to apply at night and wash it next day byany suitable shampoo. Patient was advised to take care of his diabeticcondition and keep it under control. Patient was told to treat withVehicle A and revisit after 15 days.

Patient 2^(nd) Visit:

Patient revisited 15 days after the previous visit to say that there isno improvement at all. Patient was told to repeat the same treatmentwith Vehicle A and revisit after 15 days.

Patient 3^(rd) Visit:

Patient revisited 15 days after the previous visit to say that stillthere is no improvement. Patient was told to repeat the same treatmentwith Vehicle A and revisit after 15 days.

Patient 4th Visit:

Patient revisited 15 days after the previous visit to say I he was notgetting any improvement at all. Patient was told to repeat the sametreatment with Vehicle A and revisit after 15 days.

Patient 5^(th) Visit:

Patient did not attend scheduled appointment.

While various changes may be made in the detailed compositions andprocesses of this invention, it will be understood that such changeswill be within the spirit and scope of the present invention. Havingthus described the invention in detail, it is to be understood that theforegoing description is not intended to limit the spirit and scopethereof. What is desired to be protected by Letters Patent is set forthin the appended claims.

What is claimed:
 1. A method of treating a hair-loss disorder andstimulating hair growth in a person having such hair loss disorder in aspecific area of skin of the person, comprising: topically applying tothe specific area of the skin a therapeutically effective amount of apharmacological composition comprising: a pharmaceutical carrier; an,active composition consisting of an amount of about 2% to 5% a mixtureof sodium oxalate and oxalic acid; benzoic acid in an amount of about1.5% to 6.0% by weight; Salicylic Acid in an amount of about 0.75% to3.0% by weight; and clobetasol in an amount of about 0.005% to 0.025% byweight; wherein the pharmacological composition is safe and effectivefor the treatment of the hair loss disorder in the person sandstimulating hair growth in the specific area of the skin.
 2. The methodof claim 1, wherein the mixture of sodium oxalate and oxalic acid isabout 73% to about 83% sodium oxalate and about 17% to about 27% oxalicacid.
 3. The method of claim 1, wherein the mixture of sodium oxalateand oxalic acid is about 78.44% of Sodium oxalate and about 21.56%oxalic acid.
 4. The method of claim 1, wherein the pharmaceuticalcarrier is a composition consisting of an oil and water based vehicle.5. The method of claim 4, wherein the pharmacological compositionconsists of: 2.5% by weight of the active composition, 6.0% by weight ofbenzoic acid, 3.0% by weight of Salicylic Acid, 0.005% by weight ofclobetasol; and 88.495% by weight of the oil and water based vehicle. 6.The method of claim 4, wherein the pharmacological composition consistsof: 2.5% by weight of the active composition, 6.0% by weight of benzoicacid, 0.75% by weight of Salicylic Acid, 0.025% by weight of clobetasol;and 90.725% by weight of the oil and water based vehicle.
 7. The methodof claim 1, wherein the pharmacological composition is applied at leasttwice a day to the specific area of the skin.
 8. A method of treating ahair-loss disorder and stimulating hair growth in a person having suchhair loss disorder in a specific area of skin of the person, comprising:topically applying to the specific area of the skin a therapeuticallyeffective amount of a pharmacological composition comprising: apharmaceutical carrier consisting of 88.495% by weight of an oil andwater based vehicle; an, active composition consisting of an amount ofabout 2.5% a mixture of sodium oxalate and oxalic acid; 6.0% by weightof benzoic acid; 3.0% by weight of Salicylic Acid; and 0.005% by weightof clobetasol; wherein the pharmacological composition is safe andeffective for the treatment of the hair loss disorder in the person andstimulating hair growth in the specific area of the skin.